Recall Alert
| DRAP Alert No | No I/S/10-24-41 |
| Action Date | 24th October 2024. |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public |
| Problem / Issue | The Federal Inspector of Drugs, Karachi collected the samples of Famila 150mg Injection and sent for test / analysis. The Central Drugs Laboratory, Karachi has declared batch No. 083 of Famila Injection, manufactured by M/s Zafa Pharmaceutical Laboratories (Pvt.) Ltd, Karachi, as a substandard product. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Famila 150mg Injection Reg.No. 015615 | Medroxyprogesterone acetate | Batch No. 083 Mfg Date: 02-2023 Exp Date: 02-2029 | M/s. Zafa Pharmaceutical Laboratories, Karachi |
| Risk Statement: | To comply with the Sterility testing for injections is crucial to ensure that the product is free from viable microorganisms. The samples of above mentioned product have been reported substandard based on sterility. The use of the said medicine may lead to transmission of blood borne infections and serious adverse events.. |
| Action Initiated | –The manufacturer has been directed to immediately recall the defective batch of product from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying this batch of products. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of all federating units (DRAP and Provincial Health Departments) also increased surveillance in the market to ensure the effective recall of defective products(s). –Distributors and pharmacies are advised to be vigilant and report any suspected batch of the product(s) in the supply chain to the DRAP using the online form, or by Email at gsms∂dra.gov.pk. –Regulatory field force of all federating units (DRAP, Provincial Health Departments, and States) has also increased the surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP. |
| Advice for Consumers | -Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |