Author: Administrator

FDA Advisory No. 2020-113-B || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. FRUTTI RINGS
  2. AALEY AH’S SPREAD PURE YEMA SPREAD
  3. MERCI BAÑADAS
  4. YA YAMMY DELICACIES PINIPIG NOUGAT
  5. LUTONG PAOAY CHICHACORN GARLIC ENRICHED LIGHTLY SALTED -CHEESE

The FDA verified through post-marketing surveillance that the abovementioned food products are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food product/supplement is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food products they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-113-B

FDA Advisory No. 2020-171 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. HAYNS SPECIAL YEMA, HOMEMADE
  2. LC’S ISLAND NUTS, SALTED PEANUT WITH GARLIC CHIPS
  3. LIFESTYLE GOURMET ALL NATURAL CASHEW BUTTER, NUT BAR
  4. MIRACLE LEAF MORINGA OLEIFERA, PURE MORINGA OLEIFERA TEA
  5. LIFESTYLE GOURMET HIKE TRAIL MIX

The FDA verified through post-marketing surveillance that the above mentioned food products are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 and 8115.

To report any sale or distribution of unregistered food product/food supplement, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-171

FDA Advisory No. 2020-170 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consumption of the following unregistered food products:

  1. JOPAY’S SWEET SHRIMP PASTE
  2. PINKY’S ADOBO NUTS 100 % NATIVE NUTS SUPER CRUNCHY
  3. HOMEJOY FOOD PRODUCTS FISH CRACKERS
  4. KANYAMAN NA! SKINLESS PORK LONGGANISA
  5. WESLSY TCC TCC APPLE CANDY

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and the Certificate of Product Registration (CPR) have not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose health risk to consumers.

In light of the foregoing, the public is advised not to purchase violative food products or food supplements in the market. Moreover, the public is advised to always check if a food product or food supplement is registered with the FDA. The FDA website (www.fda.gov.phhas a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food products or food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product or food supplement.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through email at [email protected] or call (02)857-1900 loc. 8112 and 8105.

To report any sale or distribution of unregistered food product or food supplement, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-170

FDA Advisory No. 2020-169 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

The Food and Drug Administration (FDA) warns the public from purchasing and consumption of the following unregistered food products and food supplement:

  1. JULIE’S™ DELICIOUS, SWEET &, CREAMY PEANUT BUTTER
  2. MICHAELA’S KITCHEN LAING
  3. MICHAELA’S KITCHEN BICOL EXPRESS
  4. ILOCOS FISH CRACKERS
  5. GFOXX JUVENTA PLUS DIETARY SUPPLEMENT

The FDA verified through post-marketing surveillance that the abovementioned food products and food supplement are not registered and the Certificate of Product Registration (CPR) have not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products and food supplement have not gone through evaluation process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose health risk to consumers.

In light of the foregoing, the public is advised not to purchase violative food products or food supplements in the market. Moreover, the public is advised to always check if a food product or food supplement is registered with the FDA. The FDA website (www.fda.gov.phhas a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food products or food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product or food supplement.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through email at [email protected] or call (02)857-1900 loc. 8112 and 8105.

To report any sale or distribution of unregistered food product or food supplement, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-169

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-169 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products and Food Supplement:

FDA Advisory No. 2020-168 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consumption of the following unregistered food products:

  1. STRIKING LOLLIPOP WITH POPPING CANDY(GRAPE)
  2. CAMPITA’S LUCBAN DELICACIES OTAP
  3. OLL BIKOL PILI PEANUT BUTTER RECIPE WITH A HEART
  4. SARMIENTO GUMMIES
  5. PANADERIA PANTOJA SANSRIVAL CHIPS

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and the Certificate of Product Registration (CPR) have not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose health risk to consumers.

In light of the foregoing, the public is advised not to purchase violative food products or food supplements in the market. Moreover, the public is advised to always check if a food product or food supplement is registered with the FDA. The FDA website (www.fda.gov.phhas a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food products or food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product or food supplement.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through email at [email protected] or call (02)857-1900 loc. 8112 and 8105.

To report any sale or distribution of unregistered food product or food supplement, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-168

FDA Advisory No. 2020-167 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consumption of the following unregistered food products:

  1. SEA PRIDE BRAND DILIS NA LUTO (FRIED ANCHOVY) MASARAP AT MALUTONG
  2. CB CANDY MIX®
  3. POP TOYS LOLLIPOP AND TOYS SWIRLY POP
  4. DUNDEE’S SPECIAL CEBU SPECIAL MANGO DICE
  5. EVELYN’S SWEET & CANDIES SPECIAL BANANA CHIPS

The FDA verified through post-marketing surveillance that the abovementioned food products are not registered and the Certificate of Product Registration (CPR) have not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot guarantee their quality and safety. The consumption of such violative products may pose health risk to consumers.

In light of the foregoing, the public is advised not to purchase violative food products or food supplements in the market. Moreover, the public is advised to always check if a food product or food supplement is registered with the FDA. The FDA website (www.fda.gov.phhas a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food products or food supplements until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product or food supplement.

All FDA Field Officers and Regulatory Enforcement Unit (REU) in coordination with the law enforcement agencies and Local Government Units (LGUs) are requested to ensure that violative products are not sold or made available in their localities or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through email at [email protected] or call (02)857-1900 loc. 8112 and 8105.

To report any sale or distribution of unregistered food product or food supplement, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-167

FDA Advisory No. 2020-166 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements:

  1. JANNAH SERPENTINA THE MIRACLE HERBS (KING OF BITTERS)
  2. HM MANGOSTEEN HERBAL DIETARY SUPPLEMENT
  3. JANNAH MALUNGGAY FOOD SUPPLEMENT
  4. RX HERBS PLUS CAYENNE PEPPER CAPSULE HERBAL DIETARY SUPPLEMENT

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not authorized and the Certificates of Product Registration (CPR) have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food/supplement is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food supplements they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-166

FDA Advisory No. 2020-113-A || Lifting the Advisory of the Registered Food Product TITAY’S FOOD PRODUCTS Rosquillos under FDA Advisory No. 2020¬113 Subject “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Product”

The Food and Drug Administration (FDA) informs the public that the food product TITAY’S FOOD PRODUCTS Rosquillos is registered by the Market Authorization Holder, Titay’s Lilo-an Rosquillos & Delicacies, Inc., in accordance to existing FDA rules and regulations

Accordingly, the list released in FDA Advisory No. 2020-113 is hereby updated to remove the aforementioned food product.

The public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing. Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

The public health warning imposed on the remaining product listed in FDA Advisory No. 2020-113 shall remain to be upheld and shall not be affected by the issuance of this advisory. Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-113-A

/ In Food Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-113-A || Lifting the Advisory of the Registered Food Product TITAY’S FOOD PRODUCTS Rosquillos under FDA Advisory No. 2020¬113 Subject “Public Health Warning Against the Purchase and Consumption of the Unregistered Food Product”

FDA Advisory No. 2020-165 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food supplements:

  1. USANA ESTROPRO WOMEN’S HEALTH SUPPLEMENT
  2. USANA VITA-ANTIOXIDANT DIETARY SUPPLEMENT
  3. GNC WOMEN’S ULTRA MEGA DIETARY SUPPLEMENT
  4. GNC WOMEN’S ULTRA MEGA 50 PLUS

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not authorized and the Certificates of Product Registration (CPR) have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food/supplement is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food supplements they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-165

FDA Advisory No. 2020-164 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. GOODBOY CHEWY PEPPERMINT
  2. JOLLEN BAKESHOPPE DICE UBE
  3. KAI-KAI GREASELESS PEANUTS
  4. DARLING FOODS CHIKARON CHILLI
  5. SWEETTY STICK PENCIL CANDY

The FDA verified through post-marketing surveillance that the abovementioned food products are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food product/supplement is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food products they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8112 or 8105.

To report any sale or distribution of unregistered food products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-164

FDA Advisory No. 2020-163 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. KIK’S SAMPALOC ORIGINAL CLASSIC FLAVOR
  2. MORINGA & MORE LEMONGRASS POWDER
  3. MORINGA & MORE TURMERIC POWDER
  4. HEALTHY YOU MANGOSTEEN GUYABANO JUICE DRINK MIX
  5. SUREBUY LIVER SPREAD

The FDA verified through post-marketing surveillance that the abovementioned food products are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 and 8105.

To report any sale or distribution of unregistered food product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No.2020-163

FDA Advisory No. 2020-161 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Products:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following unregistered food products:

  1. PRINCESS HERBAL COFFEE
  2. PREMO BRILLO CAFE SINGLE SERVE ITALIAN ROAST
  3. TAKING THE PEA COATED CRUNCHY PEAS, CHEESY PEASY & ONION
  4. FRONTIER TOPFER CREAM FILLED WAFER CUBES, STRAWBERRY CRAZE
  5. YOGI WOMAN’S MOTHER TO BE TEA BAGS

The FDA verified through post-marketing surveillance that the abovementioned food products are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food products have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food product is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food product.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 and 8105.

To report any sale or distribution of unregistered food product, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-161

FDA Advisory No. 2020-157 || Voluntary Recall of Unisepta Foam 2 Medical Device Disinfectant 750ml

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public on the voluntary recall of Unisepta Foam 2 Medical Device Disinfectant 750ml with MDR No. 06986, imported and distributed by Dental Domain:

Dental Domain has conducted the voluntary recall of the aforementioned product due to the announcement from their supplier, USF Healthcare. According to their supplier, a contamination with gram negative bacteria Burkholderia Capacia commonly found in water has been identified in the manufacturing process of the affected products at their subcontractor. The bacteria pose little medical risk to healthy people. However, immunocompromised patients are at higher risk of infection. They have moved to test their products to ensure the safety and decontamination of the manufacturing facilities has been done.

In light of the foregoing, all concerned healthcare professional, establishment, and the general public is warned to discontinue further use, sale, and distribution of the said medical device.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that product is not sold or made available in the market or areas of jurisdiction.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Any suspected adverse reaction experienced from the use of the medical device but not limited to the lot numbers stated above should be reported immediately to FDA.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at cdrrhr@fda.gov.ph, or call (02) 857-1900 loc. 8301.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-157

FDA Advisory No. 2020-158 || Public Health Warning Against the Purchase and Use of Counterfeit Medical Device “Cos-Med Volumetric Solution Infusion Set”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the counterfeit Cos-Med Volumetric Solution Infusion Set. Please see particulars/details of the original vs. the counterfeit product  on the attachment below…

The Market Authorization Holder (MAH), Cosmo Medical, Inc., reported to the FDA that the aforementioned medical device is counterfeit.

Counterfeit product has not go through the required safety assessment and the FDA verification process. This product pose potential health hazards to the consuming public since its safety and purity cannot be guaranteed.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product.

All concerned establishments are warned not to distribute, the said counterfeit medical device.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this violative product is not sold or made available in the market or their areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this counterfeit product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.                                      

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-158

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-158 || Public Health Warning Against the Purchase and Use of Counterfeit Medical Device “Cos-Med Volumetric Solution Infusion Set”

Kapihan at Talakayan Sa FDA For Medical Device Establishments on 28 February 2020

The CDRRHR shall be holding the aforementioned activity on 28 February 2020, Friday, 9:00AM – 12:00PM at the FDA Lobby.

The Kapihan at Talakayan aims to provide a venue for the discussion, clarification and/or suggestion on the implementation of Administrative Order No. 2018-0002, Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements.

All interested parties may signify their attendance thru registration by e-mail at [email protected]. Registration shall be on a first-come, first-served basis. Only one (1) representative shall be allowed per company.

A total of 150 slots shall be made available and confirmation as attendee shall be made via e-mail.

For your information and guidance.

FDA Advisory No. 2020-156 || Public Health Warning Against the Purchase and Use of Counterfeit Medical Device “Cos-Med Inset Adult without Needle”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the counterfeit Cos-Med Inset Adult without Needle. Please see particulars/details of the original vs. the counterfeit product on the attachment below…

The Market Authorization Holder (MAH), Cosmo Medical, Inc., reported to the FDA that the aforementioned medical device is counterfeit.

Counterfeit product has not go through the required safety assessment and the FDA verification process. This product pose potential health hazards to the consuming public since its safety and purity cannot be guaranteed.

In light of the foregoing, the public is advised not to purchase the aforementioned violative product.

All concerned establishments are warned not to distribute, the said counterfeit medical device.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this violative product is not sold or made available in the market or their areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this counterfeit product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.           

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-156

FDA Advisory No. 2020-122 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Doc Check® – Nebulizer Mask”

The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the unregistered medical device:

  1. “Doc Check® – Nebulizer Mask”

The FDA verified through post-marketing surveillance that the abovementioned medical device is not registered and the Certificate of Product Registration (CPR) has not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since this unregistered medical device has not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.

In light of the foregoing, the public is advised not to purchase the violative product in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device until CPR is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of this unregistered product.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.               

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:->FDA Advisory No. 2020-122

FDA Advisory No. 2020-121 || Public Health Warning Against the Purchase and Use of the following Unregistered Medical Devices:

The Food and Drug Administration (FDA) warns the general public and all healthcare professionals against the purchase and use of the unregistered medical devices:

  1. We Bare Bears Adhesive Bandage/Plaster
  2. First Aid – Breathable & Waterproof Adhesive Bandage/Plaster (40 count)
  3. First Aid – Breathable & Waterproof Adhesive Bandage/Plaster (50 count)

The FDA verified through post-marketing surveillance that the abovementioned medical devices are not registered and the Certificates of Product Registration (CPR) have not yet been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered medical devices have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety.

In light of the foregoing, the public is advised not to purchase the violative products in the market.

All concerned establishments are warned not to distribute, advertise, or sell the said violative medical devices until CPR are issued, otherwise, regulatory actions and sanctions shall be strictly pursued.

All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.

The Bureau of Customs is urged to restrain the entry of these unregistered products.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

To report any sale or distribution of unregistered medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No. 2020-121

FDA Advisory No. 2020-159 || Public Health Warning Against the Purchase and Consumption of the following Unregistered Food Supplements:

The Food and Drug Administration (FDA) warns the public from purchasing and consuming the following food supplements:

  1. MG SQUALENE SHARK LIVER OIL FOOD SUPPLEMENT,500mg
  2. SHIROI HADA SLIMMING JELLY
  3. SHIROI HADA GLUTATHIONE JELLY
  4. NUTRI HERBS JAMUN EXTRACT FOR SUGAR CONTROL
  5. HEALTH AND NATURALS MANGOSTEEN POWER HERBAL VEGGIE CAPSULES XANTHONE FOOD SUPPLEMENT

The FDA verified through post-marketing surveillance that the abovementioned food supplements are not authorized and the Certificates of Product Registration have not been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.

Since these unregistered food supplements have not gone through evaluation process of the FDA, the agency cannot assure their quality and safety. The use of such violative products may pose health risks to consumers.

In light of the foregoing, the public is advised not to purchase the aforementioned violative products. Moreover, the public is advised to always check if a food supplement is registered with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing.

All concerned establishments are warned not to distribute violative food supplement until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a CPR for the food supplement.

All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that violative products are not sold or made available in the market or areas of jurisdiction.

Kindly contact the FDA Center for Food Regulation and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8112 and 8105.

To report any sale or distribution of unregistered food supplement, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-159

FDA Advisory No. 2019-346-C || Lifting the Advisory of the Notified Cosmetic Product “ELLIPS VITAMIN HAIR MASK NUTRI COLOR WITH TRIPLE CARE” under FDA Advisory No 2019-346 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic Products (Batch 3)” Dated 09 October 2019

The Food and Drug Administration (FDA) informs the public that the cosmetic product Ellips Vitamin Hair Mask Nutri Color with Triple Care with Notification No.  1000004923335, has been notified by the Market Authorization Holder (MAH), Kino Consumer Philippines, Inc., in accordance with existing FDA rules and regulations.

Accordingly, the list released in FDA Advisory No. 2019-346 is hereby updated to remove the aforementioned cosmetic product.

The public is advised to always check if a cosmetic product is notified with the FDA. The FDA website (www.fda.gov.ph) has a Search feature which may be used by typing in the name of the product before purchasing. Kindly contact the FDA Center for Cosmetics

Regulation and Research through e-mail at [email protected] , or call (02) 88571900 loc.  8113 or 8117,

To report any sale or distribution of unnotified cosmetic products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

The public health warning imposed on the remaining products listed in FDA Advisory No. 2019-346 shall remain to be upheld and shall not be affected by the issuance of this advisory.

Furthermore, the issuance of this advisory shall not in any manner preclude this Office from issuing subsequent orders it may deem necessary and appropriate, should there be findings of any violation of the company to the existing laws, rules, and regulations.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2019-346-C

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-346-C || Lifting the Advisory of the Notified Cosmetic Product “ELLIPS VITAMIN HAIR MASK NUTRI COLOR WITH TRIPLE CARE” under FDA Advisory No 2019-346 “Public Health Warning Against the Purchase and Use of Unnotified Cosmetic Products (Batch 3)” Dated 09 October 2019

FDA Advisory No. 2020-155-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng mga hindi rehistradong gamot na:

  1. Chuan Chiong Liu Wei Di Huang Wan (Concentrated Pill) 240 Pills
  2. Chuan Chiong Liu Wei Di Huang
  3. Growful “204” Wei Te Ling

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing mga gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na mga produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02)8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:->FDA Advisory No.2020-155-A

FDA Advisory No. 2020-155 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. Chuan Chiong Liu Wei Di Huang Wan (Concentrated Pill) 240 Pills
  2. Chuan Chiong Liu Wei Di Huang
  3. Growful “204” Wei Te Ling

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore consumption of such violative products may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02)8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link:https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-155

FDA Advisory No. 2020-154-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng mga Hindi Rehistradong Gamot na:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. Pagkabuhay Herbal Healing Oil 60ml
  2. H. Ginger Herbal Healing Oil 60ml    
  3. H. Eucalyptmint with Peppermint Herbal Healing Oil All Natural 60ml
  4. H. Ginger Herbal Healing Vicks
  5. Pagkabuhay Herbal Healing Vicks

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing mga gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing mga iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing mga iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing mga iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang mga produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga hindi rehistradong gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primary reporting.who-umc.org/Reporting/Reporter?OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No.2020-154-A

FDA Advisory No. 2020-154 || Public Health Warning Against the Purchase and Use of the Following Unregistered Drug Products:

The Food and Drug Administration (FDA) advises the public against the purchase and use of the following unregistered drug products:

  1. Pagkabuhay Herbal Healing Oil 60ml
  2. H. Ginger Herbal Healing Oil 60ml    
  3. H. Eucalyptmint with Peppermint Herbal Healing Oil All Natural 60ml
  4. H. Ginger Herbal Healing Vicks
  5. Pagkabuhay Herbal Healing Vicks

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug products have not gone through the registration and testing process of the Agency and have not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative products may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative products and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug products until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-154

FDA Advisory No. 2020-153-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Agua (Cleansing Solution) 60mL

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. Agua (Cleansing Solution) 60mL

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga pekeng gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/ Reporting/Reporter? OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No.2020-153-A

FDA Advisory No. 2020-153 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Agua (Cleansing Solution) 60mL

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

  1. Agua (Cleansing Solution) 60mL

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. Therefore, consumption of such violative product may pose potential danger or injury to health.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-153

FDA Advisory No. 2020-152-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Family Care™ Original Strength Bacitracin First Aid Antibiotic Ointment USP 0.5 oz (14g)

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. Family Care Original Strength Bacitracin First Aid Antibiotic Ointment USP 0.5 oz (14g)

Napatunayan sa pamamagitan ng isinagawang Post-Marketing Surveillance (PMS) ng FDA na ang nasabing gamot ay hindi dumaan sa proseso ng rehistrasyon o pag-eeksamin ng Ahensya at hindi nabigyan ng kaukulang awtorisasyon tulad ng Certificate of Product Registration (CPR). Samakatuwid, hindi masisiguro ng Ahensya ang kalidad at kaligtasan nito. Ang nasabing iligal na produkto ay maaaring magdulot ng panganib sa kalusugan ng mga gagamit nito.

Alinsunod sa Republic Act No. 9711, o ang Food and Drug Administration Act of 2009, ang paggawa, pag-angkat, pagbenta, pamamahagi, paglipat, promosyon, pagpapatalastas o sponsorship ng produktong pangkalusugan nang walang kaukulang awtorisasyon mula sa FDA ay ipinagbabawal.

Ang publiko ay pinapaalalahanang huwag bumili ng nasabing iligal na produkto at maging maingat laban sa mga ito. Ugaliing tingnan kung ang gamot ay rehistrado sa FDA bago bilhin, sa pamamagitan ng paggamit ng Search feature ng FDA website sa www.fda.gov.ph. Maaari ring tingnan ang FDA Registration number sa label ng produkto.

Ang lahat ng establisyamento at/o entidad ay binabalaang huwag mamahagi ng nasabing iligal na produkto hanggang sa ito ay mabigyan ng kaukulang awtorisasyon, sapagkat kaukulang parusa ay mahigpit na ipatutupad.

Hinihiling sa lahat ng Local Government Units (LGUs) at Law Enforcement Agencies (LEAs) na tiyaking ang produktong ito ay hindi maibebenta o magagamit sa kanilang mga nasasakupan.

Para sa karagdagang impormasyon at katanungan, maaaring mag-email sa [email protected]. Upang mag-report ng patuloy na pagtitinda o pangangalakal ng mga pekeng gamot, mag-email sa [email protected], o mag-report gamit ang aming online reporting facilityeReport, sa www.fda.gov.ph/ereport. Maaari ring tumawag sa Center for Drug Regulation and Research (CDRR) sa numerong (02) 8809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: https://primaryreporting.who-umc.org/ Reporting/Reporter? OrganizationID=PH at kumpletuhin ang mga kinakailangang impormasyon.

Ang lahat ay hinihikayat na palaganapin ang mga nakasaad na impormasyon.

Attachment:-> FDA Advisory No.2020-152-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-152-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Family Care™ Original Strength Bacitracin First Aid Antibiotic Ointment USP 0.5 oz (14g)

FDA Advisory No. 2020-152 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Family Care™ Original Strength Bacitracin First Aid Antibiotic Ointment USP 0.5 oz (14g)

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

  1. Family Care  Original Strength Bacitracin First Aid Antibiotic Ointment USP 0.5 oz (14g)

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative product may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-152

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-152 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Family Care™ Original Strength Bacitracin First Aid Antibiotic Ointment USP 0.5 oz (14g)

FDA Advisory No. 2020-151-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Methyl Salicylate (Georgine Magson Herbal Oil) 60ml

Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

  1. Methyl Salicylate (Georgine Magson Herbal Oil) 60ml

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative product may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-151-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-151-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Methyl Salicylate (Georgine Magson Herbal Oil) 60ml

FDA Advisory No. 2020-151 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Methyl Salicylate (Georgine Magson Herbal Oil) 60ml

The Food and Drug Administration (FDA) advises the public against the purchase and use of the unregistered drug product:

  1. Methyl  Salicylate  (Georgine Magson Herbal Oil) 60ml

FDA Post-Marketing Surveillance (PMS) activities have verified that the abovementioned drug product has not gone through the registration and testing process of the Agency and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, the Agency cannot guarantee their quality and safety. The consumption of such violative product may pose potential danger or injury if administered.

Pursuant to Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, promotion, advertising or sponsorship of health products without proper authorization from FDA is prohibited.

In light of the above, the public is advised not to purchase the aforementioned violative product and to be vigilant against it. Always check if a drug product has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website accessible at www.fda.gov.ph. You may also look for the FDA Registration number on the product label.

All concerned establishments and/or entities are warned not to distribute the above-identified violative drug product until they have already been covered by the appropriate authorization, otherwise, regulatory actions and sanctions shall be strictly pursued.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that these products are not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA Advisory No.2020-151

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2020-151 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Methyl Salicylate (Georgine Magson Herbal Oil) 60ml