Recall Alert
VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG LABORATORIES, KARACHI.
| DRAP Alert No | No I/S/11-25-115 |
| Action Date | 27 November, 2025. |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers |
| Problem / Issue | Provincial Drug Testing Laboratories, Punjab informed that the sample of below mentioned Veterinary Drug products have been declared as ‘Substandard’. |
Therapeutic Goods (s) Affected: –
| S# | Product Details | Batch # | Manufacturer details | Remarks |
| 1. | Tribrissen Injection 48% Each 100ml vial contains: Trimethoprim, BP…….8%w/v Sulfadiazine, BP…..40% (Reg. # 091891) | 157884 | M/s Hilton Pharma (Pvt) Ltd. Plot No. 13 & 14 Sector 15 Korangi Industrial Area Karachi. (DML # 000543) | The sample sample is Sub-Standard, on the basis Assay and Sterility Tests performed as per BP. |
| Risk Statement: | Use of a non-sterile or sub-potent veterinary injectable poses a significant risk of severe local infections, fever, systemic illness, treatment failure, and increased mortality in treated animals. Animals receiving ineffective therapy may continue to carry and spread infections, increasing the likelihood of disease transmission within herds. In addition, animals that develop injection-site abscesses or systemic reactions may produce unsafe milk or meat, posing a public-health risk, particularly where veterinary medicines enter the food chain without adequate withdrawal periods. The public most likely to be affected include farmers, livestock handlers, consumers of raw milk/meat, and community’s dependent on these animals for food or livelihood. |
| 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 and livestock owners are advised to immediately stop using the affected batch and isolate all remaining stock. Closely monitor treated animals for fever, swelling at the injection site, reduced appetite, or any sudden illness, and consult a veterinarian if such symptoms appear. Until animals are clinically stable, avoid selling or using milk or meat from visibly unwell animals. The affected product should be returned to the supplier or distributor according to recall instructions. Farmers are further advised to maintain proper records of batch numbers, treatment dates, and suppliers for traceability, and to ensure that only sterile, approved veterinary injections are used and stored under recommended conditions. |