Author: Administrator

FDA Advisory No. 2019-486 || CONSUMER INFORMATION ON THE PURCHASE AND USE OF TOYS AND CHILD CARE ARTICLES (TCCA) DURING HOLIDAY SEASON

The Food and Drug Administration (FDA) is reminding the general public, especially the parents, to be more careful and vigilant in buying Toys and Child Care Articles (TCCAs) during the holiday season as these products are often purchased as Christmas gifts for children.

Pursuant to the Implementing Rules and Regulation of Republic Act 10620, otherwise known as “Toy and Game Safety Labeling Act of 2013” Title II sec.1, the following information shall appear on the package, container, wrapper or protective covering to guide consumers on how to use a toy, what ages the toy is safe for and to know how to use the toy in the right way: (See attached infographics for easy reference)

  1. License to Operate number issued by FDA
  2. Age grading
  3. Cautionary Statement/Warnings
  4. Instructional Literature
  5. Manufacturer’s markings (name and address of the local company)
  6. Item Model / Stock Keeping Unit (SKU) number

Failure to declare the above labeling information is considered as misbranded or banned hazardous substances and shall not be allowed to be distributed or sold in the market.

Further, consumers are encouraged to check the website (https://ww2.fda.gov.ph/index.php/consumers-corner/toys-and-childcare-artiles-notification) for the list of notified TCCA products for information on toy safety and to purchase only notified Toys and Child Care Articles (TCCAs) distributed by FDA licensed manufacturer/trader/distributor.

For more information or clarification, kindly email us at [email protected].

Attachment:-> FDA Advisory No.2019-486

Conduct of the 2019 National Food and Drug Administration Field Regulatory Operations Office (FDA FROO) Conference on 9-12 December 2019

In view of the conduct of the 2019 National FDA-FROO Conference on 9-12 December 2019, pursuant to FDA Personnel Order No. 2019-0836 dated 29 November 2019, please be informed that the FDA Regional Field Offices will be receiving limited transactions only.
 
Clients are encouraged to send queries and concerns on the respective regional e-mail address.
 
For information and guidance.

CDRR Officers of the Day for 9-11 and 13 December 2019

In view of the Performance Review and other FDA activities scheduled on 9-11,13 December-2019, please be- informed that there will be no CDRR officers on duty for the said dates at the FDA Action Center (FDAC).

We advise our clients to kindly send all queries and concerns via [email protected], and we will respond accordingly. Walk-in clients may also opt to approach the Public Assistance desk located in the FDAC.

For your information and guidance.

Attachment:->CDRR Officers of the Day for 9-11 and 13 December 2019

FDA Advisory No. 2019-475 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Modroc Plaster of Plaster of Paris 8cm x 3m x 3 Rolls”

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

  1.  “Modroc Plaster of Plaster of Paris 8cm x 3m x 3 Rolls”

The FDA verified through post-marketing surveillance that the abovementioned medical device is 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 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) 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.2019-475

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-475 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Modroc Plaster of Plaster of Paris 8cm x 3m x 3 Rolls”

FDA Advisory No. 2019-474 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Shengde Digital Infrared Thermometer”

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

  1. Shengde Digital Infrared Thermometer”

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) 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.2019-474

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-474 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “Shengde Digital Infrared Thermometer”

FDA Advisory No. 2019-464 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices Advertised for sale in Lazada.com.ph

The Food and Drug Administration (FDA) warns the general public and all healthcare professionals against the purchase and use of the unregistered medical devices advertised for sale in lazada.com.ph:

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. 2019-464

VENUE FOR QCFRR-MIN ON 3-4 DECEMBER 2019 AND GMP-FMT-MEC ON 5 DECEMBER 2019

Please be informed that the venue of the Center for Food Regulation and Research QPIRA Seminar for Mindanao Stakeholders, Course Code: QCFRR-Min on 3-4 December 2019 and GMP-FMT for Mindanao East Stakeholders, Course Code: GMP-FMT-MEC on 5 December 2019 will be in PINNACLE HOTEL AND SUITES, STA. ANA AVE., POBLACION DISTRICT, DAVAO CITY.

All registrants who received Course Assessment Slips but have not yet received their Course Confirmation Slips are advised to bring with them the following documents:

  • Course Assessment Slip
  • Proof of Payment
  • Valid ID

 For inquiries and other concerns, please call the FDA Academy at telephone number (02) 877 0259.

Attachment:-> VENUE FOR QCFRR-MIN and GMP-FMT-MEC

FDA Advisory No. 2019-462 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Pure-Aid Gauze Pads”

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

  1. Pure-Aid Gauze Pads

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 their 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. 2019-462

FDA Advisory No. 2019-461 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Natureplex Warm Touch Warming Jelly”

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

  1. Natureplex Warm Touch Warming Jelly

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 their 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. 2019-461

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-461 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Natureplex Warm Touch Warming Jelly”

FDA Advisory No. 2019-460 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Dr. Sheffield’s Lubri-Gel Personal Lubricant Jelly”

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

  1. Dr. Sheffield’s Lubri-gel Personal Lubricant Jelly

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 their 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. 2019-460

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-460 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Devices “Dr. Sheffield’s Lubri-Gel Personal Lubricant Jelly”

#MedSafetyWeek (28 November 2019)

New problems in a patient on multiple medications may be side effects or interactions. Is your patient taking too many products? Review their prescriptions and report any side effects:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

#MedSafetyWeek
#PhFDA

KAPIHAN AT TALAKAYAN SA FDA FOR MANUFACTURERS AND DISTRIBUTORS OF FOOD CONTRACT ARTICLES

The Toxicology Section of the Common Services Laboratory (CSL) shall be holding the aforementioned activity on 04 December 2019 (Wednesday) 9:30 AM — 12:00 PM at the Food and Drug Action Center (FDAC) Meeting Room, located at 3rd Level of Starmall, Alabang, Muntinlupa City.

The Kapihan at Talakayan aims to provide a venue for discussion, clarification, and/or suggestion on the implementation of FDA Citizen’s Charter on Application for Food Suitability Evaluation of Food Contact Articles (Voluntary).

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

A total of fifteen (15) slots shall be made available and confirmation as attendee shall also be made via e-mail.

For your information and guidance.

Attachment:-> KAPIHAN AT TALAKAYAN SA FDA FOR MANUFACTURERS AND DISTRIBUTORS OF FOOD CONTRACT ARTICLES

FDA Advisory No. 2019-465 || Lifting the Advisory on the Following Registered Medical Devices under FDA Advisory No. 2019-342 and 2019-343 “Luxe Organix Hydrocolloid Acne Spot Patch Day Time and Luxe Organix Hydrocolloid Acne Spot Patch Night Time”

The Food and Drug Administration (FDA) informs the public that the following medical devices have been registered by the Market Authorization Holder (MAH), Genson Distribution, Inc., in accordance to existing FDA rules and regulations.

1. Luxe Organix Hydrocolloid Acne Spot Patch Day Time, with Registration No. MDR-08696.
2. Luxe Organix Hydrocolloid Acne Spot Patch Night Time, with Registration No. MDR-08697. 

Accordingly, the warning against the purchase and use of the products as mentioned in FDA Advisory No. 2019-342 and 2019-343 is hereby lifted.

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 products, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.

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. 2019-465

/ In Device Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-465 || Lifting the Advisory on the Following Registered Medical Devices under FDA Advisory No. 2019-342 and 2019-343 “Luxe Organix Hydrocolloid Acne Spot Patch Day Time and Luxe Organix Hydrocolloid Acne Spot Patch Night Time”

#MedSafetyWeek (27 November 2019)

Sometimes you need to take more than one medicine for long-term or complex conditions. Be vigilant about side effects! Report them here:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

#MedSafetyWeek
#PhFDA

FDA Advisory No. 2019-473 || Public Health Warning Against the Purchase and Use of the following Unnotified Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unnotified cosmetic products:

  1. NIVEA® CRÈME SMOOTH BODY WASH SHEA BUTTER
  2. TEAL’S® PINK HIMALAYAN FOAMING BATH
  3. WHITE BODY ALL SKIN DEEP SEA MUD NATURAL
  4. MUZ WHITENING PLUS FACIAL SHEET MASK WHITENING + COLLAGEN
  5. MEDIHEAL W.H.P. WHITE HYDRATING BLACK MASK EX

The FDA verified through post-marketing surveillance (PMS) that the abovementioned cosmetic products are not authorized and the Certificates of Product Notification have not been issued. 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Since these unnotified cosmetic 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.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product as listed in the Annex II, Part I of the ASEAN Cosmetic Directive (ACD). The use of substandard and possibly adulterated cosmetic products may result to adverse reactions, including but not limited to, skin irritation, itchiness, anaphylactic shock, and organ failure.

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 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.

All concerned establishments are warned not to distribute violative cosmetic products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic 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 Cosmetics Regulation and Research through e-mail at [email protected] or call (02) 857-1900 local 8113 or 8107.

To report any sale or distribution of unnotified cosmetic 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.2019-473

FDA Advisory No. 2019-453 || Public Health Warning Against the Purchase and Use of the following Unnotified Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the following unnotified cosmetic products:

  1. MISTINE NATURAL MUD FACIAL MASK
  2. NEXXUS® NEW YORK SALON CARE PROMEND SPLIT END REPAIRING SYSTEM FLAX SEED OIL SHAMPOO
  3. SCALPKLENS ANTI-DANDRUFF SHAMPOO HAIR CLEANSING TREATMENT
  4. 3W CLINIC FRESH COENZYME Q1 MASK SHEET

The FDA verified through post-marketing surveillance (PMS) that the abovementioned cosmetic products are not authorized and the Certificates of Product Notification have not been issued. 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

Since these unnotified cosmetic 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.

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product as listed in the Annex II, Part I of the ASEAN Cosmetic Directive (ACD). The use of substandard and possibly adulterated cosmetic products may result to adverse reactions, including but not limited to, skin irritation, itchiness, anaphylactic shock, and organ failure.

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 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.

All concerned establishments are warned not to distribute violative cosmetic products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic 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 Cosmetics Regulation and Research through e-mail at [email protected] or call (02) 857-1900 local 8113 or 8107.

To report any sale or distribution of unnotified cosmetic 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. 2019-453

FDA Advisory No. 2019-452 || Public Health Warning Against the Purchase and Use of the following Unnotified Cosmetic Products:

The Food and Drug Administration (FDA) warns the public from purchasing and using the cosmetic following unnotified cosmetic products:

  1. VERY FASHION VERDON SERIES COFFEE HAIR REBOND PRO-HERBAL FORMULA (1)
  2. VERY FASHION VERDON SERIES COFFEE HAIR REBOND PRO-HERBAL FORMULA (2)
  3. VERDON®  NE SILKY ARGAN OIL KERATIN CARE REBONDING (2)
  4. FASHIONNATE VERDON NE SILKY SERIES KERA,TIN AVOCADO REBONDING FOR PROFESSIONAL USE ONLY
  5. VERDON®  NE SILKY NATURAL ORCANIC 1 MINUTE KERATIN BLOW OUT HAIR SPA TREATMENT

The FDA verified though post-marketing surveillance (PMS) that the abovementioned cosmetic products are not authorized and the Certificates of Product Notification have not been issued. 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, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization from FDA is prohibited.

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

Potential hazards may come from ingredients that are not allowed to be part of a cosmetic product as listed in the Annex II, Part I of the ASEAN Cosmetic Directive (ACD). The use of substandard and possibly adulterated cosmetic products may result to adverse reactions, including but not limited to, skin irritation, itchiness, anaphylactic shock, and organ failure.

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 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 puchasing.

All concerned establishments are warned not to distribute violative cosmetic products until they have been issued the appropriate authorization, a License to Operate (LTO) for the establishment, and a Certificate of Product Notification (CPN) for the cosmetic 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 Cosmetics Regulation and Research through e-mail at [email protected] or call (02) 857-1900 local 8113 or 8107.

To report any sale or distribution of unnotified cosmetic 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. 2019-452.

FDA Advisory No. 2018-327-E || Lifting the Advisory of the Notified Cosmetic Product “DROPLETS OF NATURE KOJIC ACID LOTION” under FDA Advisory No. 2018-327 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 16)” Dated 07 Decembe

The Food and Drug Administration (FDA) informs the public that the below cosmetic product has been notified by the Market Authorization Holder (MAH), Droplets of Nature, Inc., in accordance to existing FDA rules and regulations:

Droplets of Nature Kojic Acid Lotion with SPF                –Notification No. 1000001861278

Accordingly, the list released in FDA Advisory No. 2018-327 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) 857-1900 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. 2018-327 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.2018-327-E

/ In Cosmetic Advisories / By Administrator / Comments Off on FDA Advisory No. 2018-327-E || Lifting the Advisory of the Notified Cosmetic Product “DROPLETS OF NATURE KOJIC ACID LOTION” under FDA Advisory No. 2018-327 “Public Health Warning Against the Use of Unnotified Cosmetic Products (Batch 16)” Dated 07 Decembe

FDA Advisory No. 2019-463 || Public Health Warning Against the Purchase and Use of the Unregistered Medical Device “DIGITAL THERMOMETER”

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

  1. “Digital Thermometer”

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 their 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. 2019-463

FDA Advisory No. 2019-388 || Incorrect Use of Anti-Fungal Corticosteroid Combination Therapy

Nowadays, internet and social media has influenced the lives of Filipinos. Physical appearance on Facebook and Instagram posts is a great concern, it is now expected to look best all the time. And when a skin problem arises, solutions and treatment are searched through the internet instead of consulting a dermatologist to address skin problems. Unfortunately, the use of products widely available and sold in the internet and unlicensed establishments make the skin problems worse one such product is LS BL Cream containing Ketoconazole and Clobetasol and is well-known to the public to cure all types of skin problems.

Pharmacists are advised not to dispense the product without a written prescription from dermatologists or treating physician. Upon presentation of prescription, patients should undergo counselling on the proper use of the product to avoid serious health risks and worsening of their conditions.

The general public is also advised to avoid using the product without proper consultation from dermatologist. It is a prescription product used for the treatment of fungal and yeasts infections. The product contains a very potent steroid which may result in side effects such as worsening condition, acne, skin infections, skin thinning, changes to the color of skin, allergic reaction, increased weight, rounding of the face, stretch marks, etc. There is a recorded case who experienced side effect on the use of Ketoconazole + Clobetasol cream which eventually resulted to death due to staphylococcal scalded skin syndrome associated with the use of topical steroid.

We strongly urge the public to buy medicines only from an FDA licensed drugstores and avoid buying medicines online.

Also, please be informed that there is a proliferation of Ketoconazole + Clobetasol Propionate (LS BL Cream) 10 g in the market which is not registered to the Food and Drug Administration (FDA). The drug product has not gone through the registration and testing process and has not been issued with proper authorization in the form of Certificate of Product Registration. Thus, we cannot guarantee their quality and safety.

Seek medical attention immediately if you experience any side effects and report it to FDA via online reporting through our website: www.fda.gov.ph or email at [email protected]. You may also reach us at telephone number (02) 8809-5596.

Attachment:-> FDA Advisory No. 2019-388

#MedSafetyWeek (26 November 2019)

Some medicines should not to be taken with other medicines or with certain foods. Always read the leaflet and report any side effects:

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH

#MedSafetyWeek
#PhFDA

 

FDA Advisory No. 2019-472-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Ravi Mangosteen Power Liniment with Negative Ion 60mL

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

  1. Ravi Mangosteen Power Liniment with Negative Ion 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 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) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:-> FDA ADVISORY No. 2019-472-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-472-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Ravi Mangosteen Power Liniment with Negative Ion 60mL

FDA Advisory No. 2019-472 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Ravi Mangosteen Power Liniment with Negative Ion 60mL

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

  1. Ravi Mangosteen Power Liniment with Negative Ion 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)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA ADVISORY No. 2019-472

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-472 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Ravi Mangosteen Power Liniment with Negative Ion 60mL

FDA Advisory No. 2019-471-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Menthol + Eucalyptus Oil (Ugat Bicks)

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

  1. Menthol + Eucalyptus Oil (Ugat Bicks)

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 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) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:-> FDA ADVISORY No. 2019-471-A

FDA Advisory No. 2019-471 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Menthol + Eucalyptus Oil (Ugat Bicks)

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

  1. Menthol + Eucalyptus Oil (Ugat Bicks)

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)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA ADVISORY No. 2019-471

FDA Advisory No. 2019-470-A || Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

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

  1. Povidone-Iodine 10% Sol.

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 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) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:-> FDA ADVISORY No. 2019-470-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-470-A || Pinapayuhan ng Food and Drug Administration (FDA) ang publiko laban sa pagbili at paggamit ng hindi rehistradong gamot na:

FDA Advisory No. 2019-470 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Povidone-Iodine 10% Sol.

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

  1. Povidone-Iodine 10% Sol.

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)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA ADVISORY No. 2019-470

FDA Advisory No. 2019-469-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Family™ Care Quickly Relieves Itching & Redness Maximum Strength Hydrocortisone 1% Anti-Itch Cream

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

  1. Family™ Care Quickly Relieves Itching & Redness Maximum Strength Hydrocortisone 1% Anti-Itch Cream

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 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) 809-5596.  Para sa mga hinihinalang hindi kanais-nais na reaksyon sa gamot, i-report agad sa FDA gamit ang link na ito: www.fda.gov.ph/adr-report-new at kumpletuhin ang mga kinakailangang impormasyon.

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

Attachment:-> FDA ADVISORY No. 2019-469-A

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-469-A || Babala sa Publiko Tungkol sa Pagbili at Paggamit ng Hindi Rehistradong Gamot na Family™ Care Quickly Relieves Itching & Redness Maximum Strength Hydrocortisone 1% Anti-Itch Cream

FDA Advisory No. 2019-469 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Family™ Care Quickly Relieves Itching & Redness Maximum Strength Hydrocortisone 1% Anti-Itch Cream

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

  1. Family™ Care Quickly Relieves Itching & Redness Maximum Strength Hydrocortisone 1% Anti-Itch Cream

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)809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

Attachment:-> FDA ADVISORY No. 2019-469

/ In Drugs Advisories / By Administrator / Comments Off on FDA Advisory No. 2019-469 || Public Health Warning Against the Purchase and Use of the Unregistered Drug Product Family™ Care Quickly Relieves Itching & Redness Maximum Strength Hydrocortisone 1% Anti-Itch Cream