Recall Alert
DRAP Alert No | No I/S/12-24-57 |
Action Date | 31st 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 | DDCP PV Lahore and Secretary PQCB Quetta have informed DRAP regarding the recall of the following batches of the mentioned products: |
Therapeutic Good(s) Affected: –
Sr.No. | Product Names | Composition | Manufactured by | Test Results |
1. | Injection I-Vitamin Super 100ml (FOR VET USE ONLY) Reg# 062066 | Each ml contains: sodium Selenite 0.5mg, Vit. E 70mg, Vit. B12 0.1mg, Vit. B1 20mg, Adenosine-5 Monophosphate 5mg Batch Number 6501 | International Pharma Labs, Raiwind Road, Bhobtian Chowk, Defence road, 1Km towards Kahna, Lahore | Adulterated and Substandard |
2. | Injection Oxytocin 50ml (FOR VET USE ONLY) Reg# 020830 | Oxytocin 10IU/ml Batch Number OXY-2219 | Lawrance Pharma (Pvt.) Ltd., 10.5 Km Shekhupura road, Lahore. | Substandard |
3. | Injection Flagyl 100ml Reg# 005102 | Metronidazole 500mg/100ml Batch Number AD354 | Sanofi-Aventis Pakistan Limited, Plot no. 23, Sector 22, Korangi Industrial Area, Karachi | Substandard |
4. | Capsule Esopase 20mg Reg# 045914 | Esomeprazole 20mg Batch Number 3K159 | Lucky Core Industries Ltd., 32/2A, Phase 3, Industrial Estate Hattar | 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 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. |