Recall Alert
VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG LABORATORIES, KARACHI.
| DRAP Alert No | No I/S/10-25-100 |
| Action Date | 24 October, 2025. |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers |
| Problem / Issue | Drugs Testing Laboratories from Provinces informed that the sample of below mentioned Veterinary products have been declared as ‘Substandard / Misbranded’. |
Therapeutic Goods (s) Affected: –
| S# | Product Details | Batch # | Manufacturer details | Remarks |
| 1. | Injection Ivotek 100ml Each ml contains: Ivermectin……….10mg (Reg. # 016284) | VM 957 | M/s Star Laboratories (Pvt.) Ltd. (Animal Health Care Division) 23 Km Multan Road Lahore. (DML # 000130) | The sample is Sub-Standard with regards to Assay and Test for related substances. |
| 2. | Injection Ivergen 10ml Each ml contains: Ivermectin………10 mg (Reg. # 023432) | 607.IV | M/s Symans Pharmaceuticals (Pvt) Ltd. 10-Km Sheikhupura Road Lahore. (DML # 000323) | The sample is Sub-Standard with regards to Assay and Test for related substances. |
| 3. | Rasomycin-5 Injection 100 ml Each ml contains: Oxytetracycline HCl …. 50 mg (Reg. # 003791) | VM406 | M/s Star Laboratories (Pvt.) Ltd. (Animal Health Care Division) 23 Km Multan Road Lahore. (DML # 000130) | The sample is Misbranded with regards to labelling as defined under Section 3(s)(iv) of the Drugs Act,1976 and Substandard on the basis of Bacterial Endotoxin Test. |
| Risk Statement: | Farmers, livestock owners, and veterinarians using these products for treatment of cattle, sheep, goats, and other farm animals are the groups most likely to be affected. The use of such defective medicines can result in loss of animal productivity, therapeutic failure, or potential residues in milk and meat, thereby posing economic and food-safety concerns for the public. |
| Action Initiated | – The regulatory field force of DRAP and Provincial Drug Control departments has 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 returned to the supplier/company. –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 Veterinarian | This alert applies strictly to the specific batches listed above and does not apply to other batches of the same products. Veterinarians are therefore advised not to prescribe, administer, or stock these identified batches under any circumstances. In case any of the above-mentioned batches have already been administered, treated animals should be closely monitored for possible signs of infection, treatment failure, or adverse reactions, and appropriate supportive care must be provided. Any suspected adverse events or quality-related problems linked to these batches should be reported immediately to DRAP’s Pharmacovigilance Centre and to the Provincial Livestock & Dairy Development Departments. Practitioners are further advised to ensure that only alternative registered and quality-assured batches are used in veterinary practice. |
| Advice for Farmers and Livestock Owners | Farmers, livestock owners, and animal handlers are advised not to use the above-mentioned batches of Injection Ivotek (Batch No. VM 957), Injection Ivergen (Batch No. 607.IV), and Rasomycin-5 Injection (Batch No. VM406). Discontinue use immediately if already in possession of these products and isolate any remaining stock. If the product has already been administered, observe animals closely for signs of fever, swelling at the injection site, weakness, or lack of therapeutic response, and consult a qualified veterinarian if any abnormal signs occur. Only purchase and use registered veterinary medicines obtained through licensed distributors or veterinary outlets. Return any suspected or recalled stock to the supplier and report details to the nearest Provincial Drug Control Office or the Drug Regulatory Authority of Pakistan (DRAP) for appropriate action. |