Recall Alert
DRAP Alert No | No I/S/01-25-02 |
Action Date | 2nd January, 2025. |
Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics – General Public |
Problem / Issue | DDCP PV Lahore has informed DRAP regarding recall of following batches of mentioned products: |
Therapeutic Good(s) Affected: –
Sr.No. | Product Names | Composition | Manufactured by | Test Results |
1. | Rasmic suspension 60ml Reg# 032405 | (Mefenamic acid 50mg/5ml) Batch Number 4H099 | Rasco Pharma 5.5Km, Raiwind road, Lahore | Contains Ethylene Glycol (EG) 2.19% that is above permissible limits. |
2. | Resfyl cough syrup 60ml Reg# 057214 | (Acefylling Piperzine 45mg, Diphenhydramine HCl 8mg) Batch Number 4A009 | Rasco Pharma 5.5Km, Raiwind road, Lahore | Contains Ethylene Glycol (EG) 1.676 % that is above permissible limits |
3. | Neocobal Injection 1ml Reg# 071447 | (Mecobalamin 0.5mg/ml) Batch Number S-2214 | Pulse Pharmaceuticals (Pvt.) Ltd., Sua Aasil, Raiwind road, Lahore | Substandard & Adulterated |
4. | Safemed infusion 100ml Reg# 045824 | (Metronidazole 500mg/100ml) Batch Number S-790 | Ahad International Pharmaceuticals Ltd., 13Km Gomal University, Multan Road, Dera Ismail Khan | Substandard |
Action Initiated | -The regulatory field force of DRAP and Provincial Drug Control departments have been requested to immediately conduct market surveys for detection and removal of these products from the market. –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. |
Advice for Healthcare Professionals | DRAP request 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 products bearing the affected batch number(s). Consumers should contact their physician or healthcare provider(s) if they have experienced any problems that may be related to using this product. -All therapeutic products must be obtained from authorised licensed pharmacies/outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |