Rapid Alert
Suspected Falsified Product
| DRAP Alert No | NoI/S/11-22-37 |
| Action Date | 28th November 2022 |
| Target Audience | 1. Regulatory Field Force 2. Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores 3. Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals, Clinics and Healthcare Institutions 4. General Public |
| Problem Statement | During the market surveillance activities in different areas of Ferozewala District Sheikhupura Punjab, Regulatory Field Force has identified the suspected sample of Xanax 0.5mg Tablets and sent for analysis. The Provincial Drugs Testing Laboratory, has declared the samples as “spurious” based on the analysis report. Details of the falsified product is as under: – |
Therapeutic Good(s) Affected:-
| Sr | Product Name | Composition | Batch # | Manufactured by (as stated on label) |
|---|---|---|---|---|
| 1 | Xanax 0.5mg Tablet | Alprazolam 0.5mg | FM7597 | M/s Pfizer Pakistan Ltd, B-2, S.I.T.E, Karachi. |
| Action Initiated | The Regulatory Field Force has been directed to increase the market surveillance and confiscate this batch of the product. All Pharmacists and chemists working at distributions and Pharmacies should immediately check the stock and stop supplying this product. The remaining stock should be quarantine immediately, and supplier(s) information should be provided to the Regulatory field force (DRAP, Provincial Health Departments and States) in order to ensure the removal of this falsified product. |
| Advice for Healthcare Professionals | -DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of above-mentioned product(s). -Adverse reactions or quality problems experienced with the use of this product shall 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 reporting problems to DRAP. |
| Advice for Consumers | -Consumers should stop using this product 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, and report the incident to Drug Regulatory Authority of Pakistan / National Pharmacovigilance Centre. -All therapeutic goods must be obtained only from the licensed pharmacies, and other authorized / licensed retail outlets. The authenticity and condition of products should be carefully checked. Seek advice from your pharmacists or other healthcare professionals in case of any doubt. |