Recall Alert
| DRAP Alert No | No I/S/04-25-40 |
| Action Date | 22nd April, 2025. |
| Target Audience | – National Regulatory Field Force of DRAP and Provincial Drug Control Departments – Healthcare Professionals – Veterinarians – Farmers/consumers |
| Problem / Issue | Directorate of Drug Control (DDC) Punjab has informed Drug Regulatory Authority of Pakistan that the samples of below mentioned products have been reported as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| Product Names | Composition | Batch Details | Manufactured by | Test Results |
|---|---|---|---|---|
| Atopin Injection For Veterinary use only Reg. No. 062122 | Each ml contains: Atropine Sulphate..…..1mg (50mL) | 376.ATP | M/s Symans Pharmaceuticals (Pvt) Ltd., 10Km, Sheikhupura Road, Lahore. | ‘Substandard’ on the basis of Bacterial Endotoxin Test. |
| Risk Statement: | Failure of the Bacterial Endotoxin Test (BET) for an injectable product may result in the release of a product with pyrogenic contamination. This may pose a significant risk of febrile reactions, endotoxic shock, or other serious adverse effects in animals. |
| Action Initiated | The field force of DRAP and Provincial Drug Control departments have been directed to immediately conduct market surveys for detection of presence and removal of mentioned batch of the product from the market. |
| Advice for Veterinarians | DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this product. Further information on reporting problems to DRAP is available on this link. |
| Advice for Farmers/Consumers | Farmers/consumers should not use this product. They shall contact their veterinarians or healthcare provider(s) if the animal experienced any problem that may be related to using this product. |