Recall Alert
VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.
| DRAP Alert No | No I/S/03-26-06 |
| Action Date | 11 March, 2026. |
| Target Audience | · National Regulatory Field Force of DRAP and Provincial Drug Control Departments. · Healthcare Professionals-Veterinarians · Farmers/consumers |
| Problem / Issue | 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 | Injection. Penbiotic. Each vial contains: Benzyl Penicillin 500,000 I.U. Procaine Penicillin 1,500,000 I.U. Streptomycin Sulphate 5GM (Reg # 022148) | V02856 | M/s Nawans Laboratories (Pvt) Ltd. 136 Sector 15 Korangi Industrial Area Karachi. (DML # 000442) | The sample is Sub-Standard with regards to |
| 2. | Injection Ivovectin 2% Each ml contains: Ivermectin …. 20 mg (Reg # 079289) | 2523216 | M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813) | Declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances. |
| 3. | Injection CYANORAS Each ml contains: Cyanocobalamin …. 25 mcg (Reg. # 109953) | CYN-009 | M/s Ras Pharmaceuticals (Pvt) Ltd. 25-Km Lahore Road Multan. (DML # 000821) | Declared as “Sub-Standard” on the basis of Assay test and Bacterial Endotoxins Test. |
| 4. | Injection Ivergen 1% 50ml Each ml contains: Ivermectin …… 10 mg (Reg # 023432) | 605.IV | M/s Symans Pharmaceuticals (Pvt.) Ltd. 10-Km Sheikhupura Road Lahore. (DML # 000323) | Declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances. |
| 5. | Injection Ivozon 1% Each ml contains: Ivermectin …… 10 mg (Reg # 119702) | AP/RCB-024 | M/s. Amazon Pharmaceutical (Pvt) Ltd. Plot No. 10/A & 29/B, Small Industrial Estate, Bhimber, AJK (DML # 000975) | The sample is declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances. |
| 6. | Injection. SUPERMEC 10ML Each ml contains: Ivermectin …… 10 mg (Reg # 075601) | 5773 | M/s Mylabs (Pvt) Ltd. Khanka Sharif Tehsil and District Bahawalpur (DML # 000747) | The sample is declared as “Sub-Standard” on the basis of Assay Test and Chromatographic Purity Test. |
| 7. | Injection Ivotek Each ml contains: Ivermectin …… 10 mg (Reg # 016284) | VM398 | M/s Star Laboratories (Pvt) Ltd. 23 Km Multan Road Lahore. (DML # 000130) | Declared as “Sub-Standard” on the basis of Assay Test and Test for Related Substances. |
| Risk Statement: | The above-mentioned products, comprising parenteral veterinary and antimicrobial injections including Benzyl/Procaine Penicillin with Streptomycin, Ivermectin (multiple brands), and Cyanocobalamin, have been declared sub-standard on critical quality parameters such as Sterility, Assay, Related Substances, Bacterial Endotoxins, and Chromatographic Purity. Failure in sterility and endotoxin testing (particularly for Penbiotic and CYANORAS injections) poses a serious and immediate risk of septicemia, pyrogenic reactions, and treatment failure, while assay deviations and related substance impurities in multiple ivermectin products may result in under-dosing, toxicity, antimicrobial resistance, or therapeutic inefficacy. The population most likely to be affected includes livestock animals (cattle, buffaloes, sheep, goats, and poultry) receiving these veterinary injections, with indirect risk to farmers, dairy/meat consumers, and the general public through potential antimicrobial resistance development and compromised food safety. |
| 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. |