All healthcare professionals and the general public are hereby warned by the Food and Drug Administration (FDA) that the affected batch of the subject product is being recalled from the market. The details of the product are as follows:
|DRUG PRODUCT||SIMVASTATIN 20 mg FILM-COATED TABLET [PHILSTAT]|
|BATCH NO./EXP. DATE||2011558||11/2023|
|MANUFACTURER||Jiangxi Xierkangtai Pharmaceutical Co., Ltd. – North Zone, High-New Technology Industrial Zone, Pingxiang , Jiangxi, China|
|IMPORTER & DISTRIBUTOR||PhilRx Pharma Inc. – No. 6 Felipe Pike St., Bagong Ilog, Pasig City|
Based on the results of the laboratory analyses conducted by the FDA, it was found that the affected batch did not conform to the set specification of assay test. The assay of a drug product determines the (1) presence of a substance and the amount of that substance, or (2) the pharmaceutical potency of a drug. Therefore, the stated batch presents quality and efficacy concerns.
Simvastatin is indicated for the treatment of primary hypercholesterolemia or mixed dyslipidemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. It is used in the treatment of homozygous familial hypercholesterolemia (HoFH) as an adjunct to diet and other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate. Simvastatin 20 mg Film-Coated Tablet [Philstat] is packed in an Alu/PVC Blister Pack x 10’s (Box of 30’s and 100’s).
Therefore, distributors, hospitals, retailers, pharmacies, or clinics that have the affected batch of the product are instructed to discontinue further distribution, sale, and use. Likewise, all consumers are advised not to use or purchase the affected product batch and may contact PhilRx Pharma Inc. at telephone no. (02) 655-5492 or send an e-mail to [email protected] for any question or additional information regarding the recall.
All Local Government Units (LGU) and Law Enforcement Agencies (LEAs) are requested to ensure that the affected product batch is 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 the abovementioned, kindly e-mail us via [email protected]. You may also call the Center for Drug Regulation and Research at telephone number (02) 8809-5596. Any suspected adverse reaction experienced from the use of the products should be reported immediately to the FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill-out all of the required fields.
Dissemination of the information to all concerned is requested.