Recall Alert
VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
| DRAP Alert No | No I/S/10-25-95 |
| Action Date | 16th October, 2025. |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers |
| Problem / Issue | Drug Testing Laboratory from Province informed the Drug Regulatory Authority of Pakistan that the sample of below mentioned Veterinary product has been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Details | Batch # | Manufacturer details | Remarks |
| 1. | Oxytocin Injection 50ml Oxytocin Synthetic 10-IU/mL (Reg. # 019928) | V8-5 | M/s ISIS Pharmaceutical & Chemical Works. 25/1-3 Sector 12-C North Karachi Industrial Area Karachi. (DML # 000126) | The sample is declared “sub-standard” on the basis of Sterility testing. |
| Risk Statement: | The use of Oxytocin Injection 50 ml (Batch No. V8-5) declared sub-standard on the basis of sterility testing, poses a significant risk to livestock health and animal productivity. As Oxytocin is commonly administered to dairy animals such as cows and buffaloes to induce milk let-down and facilitate parturition, use of a non-sterile injection may lead to severe local infections, fever, abscesses, or systemic septicemia in treated animals. This can result in economic losses to farmers and potential contamination of milk supply. All veterinarians, livestock owners, and distributors are therefore advised to immediately discontinue the use and sale of the affected batch and ensure that only quality-assured and sterile veterinary injectable preparations are procured from licensed sources. |
| 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, dairy owners, and animal keepers are strictly advised not to use these identified batches for their cattle or other livestock, as they may cause serious illness, infection, treatment failure, or even death in animals. If any of these batches have already been given, animals should be observed carefully for unusual symptoms such as fever, weakness, swelling at the injection site, or lack of recovery, and immediate veterinary assistance should be sought. Farmers are further advised to return such products to their supplier and use only safe, registered, and quality-assured veterinary medicines and vaccines to protect the health of their animals and avoid financial losses. |