Recall Alert
| DRAP Alert No | NoII/S/09-22-21 |
| Action Date | 6th October, 2022 |
| Target Audience | 1. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 2. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Providing Institutions 3. General Public |
| Product(s) Affected | Fentos 50mg Tablets, Active Ingredient(s): Diclofenac Potassium Company: M/s. Hisum Pharmaceutical Insutries Gadoon, Pakistan Batch No. 599 Manufacturing Date: Sep-2021, Expiry Date: Sep-2023 |
| Problem Statement | The Central Drug Laboratory Karachi has analyzed the sample of Fentos 50mg Tablets (Registration No. 047810) bearing Batch No. 599, and declared it as Substandard. The company has been directed to recall the affected batch of product from the market. |
| Action to be taken | -All Pharmacists and chemists working at distributions and Pharmacies are required to immediately return the stock of above mentioned batch of product to the company. -Distributors and pharmacies are advised to be vigilant and report any suspected batch of product(s) in the supply chain to the DRAP using online form, or through phone at +92 51 910 73 17, or Email at gsms∂dra.gov.pk. -Regulatory field force of all federating units (DRAP, Provincial Health Departments and States) have also increased surveillance in the market to ensure the effective recall of defective product(s). |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance within the supply chains of healthcare institutions and hospital pharmacies. -Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using 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 this product bearing the affected batch number(s) and shall contact to their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. All drug products must be obtained from authorized licensed sources/outlets. Their authenticity and condition should be carefully checked. Seek advice from a healthcare professional in case of any doubt. |