Recall Alert
| DRAP Alert No | No I/S/12-24-54 |
| Action Date | 12th December, 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 | Federal Government Analyst, CDL Karachi vide test report No. LHR-10-24-000007 has declared the subject mentioned batch of product Nocox tablet as of substandard quality. Details of CDL test report are as under |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by |
|---|---|---|---|
| Nocox Tablet (Reg# 052499) | Meloxicam 15mg | Batch no. 8463 Mfg date: 02/2024 Expiry date: 02/2026 | M/s. Alfalah Pharma (Pvt.) Ltd., 12-km Lahore Rd, Jamal Park, Sheikhupura |
| Risk Statement: | Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) commonly used to reduce inflammation and pain in conditions such as arthritis. The identified quality issue with these tablets may result in Reduced Efficacy, depending on the degree of substandard quality and the patient’s condition. Vulnerable populations, including elderly patients and those with existing gastrointestinal, cardiovascular, or renal conditions, may be at a higher risk. |
| Action Initiated | -The regulatory field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection and removal of these products from the market. All pharmacists and chemists working at distributors and pharmacies should immediately check their stocks and stop supplying these products. The remaining stocks should be quarantined, and the information of their supplier should be immediately provided to their area drug inspector to ensure the removal of falsified product. –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. |