03. Recall Alert (Class-I) – Veterinary Drug Products reports from DTLs Punjab.

VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG TESTING LABORATORIES.

DRAP Alert No	No I/S/02-26-03
Action Date	12 February, 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. I-PENRIT-5 Each vial contains Procaine Penicillin…..1500000 iu, Benzyl Penicillin……500000 iu, Streptomycin Sulphate….5 gm (Reg # 079517)	AM-164	M/s International Pharma Labs. Raiwind Road Bhobtian Chowk Defence Road 1-Km Toward Kahna, Lahore. (DML # 000582)	The sample is Sub-Standard with regards to Sterility Test .
2	Duralin 50 Injection OXYTETRACYCLINE ……..50MG/ml (Reg # 078206)	5782	M/s Mylabs (Pvt) Ltd. Khanka Sharif Tehsil and District Bahawalpur. (DML # 000747)	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 Sterility Test.
3.	Ivotek Injection Ivermectin 10 mg/ml (Reg # 016284)	VM583	M/s Star Laboratories (Pvt) Ltd. 23 Km Multan Road Lahore. (DML # 000130)	The sample is Sub-Standard with regards to Related substance.
4.	Oxytovetz injection 50 ml Oxytocin 10IU/ML	25129681	M/s Vetz Pharmaceutical (Pvt) Ltd. Plot No. Q-1 SITE Kotri Sindh (DML # 000813)	The sample is Sub-Standard with regards to Sterility Test & Assay test .

Risk Statement:	These veterinary medicines present a moderate to high risk, primarily affecting livestock health and indirectly the general public. Substandard sterile injectable antibiotics (Penicillin/Streptomycin and Oxytetracycline) failing sterility tests may cause severe infections, abscess formation, treatment failure, and animal deaths, particularly in dairy cattle, poultry, and farm animals. Misbranding and quality defects can also lead to incorrect dosing and misuse by farmers and veterinarians. Substandard ivermectin with related substance issues may reduce effectiveness against parasites and increase the risk of drug resistance. Oxytocin injection failing sterility and assay tests is of serious concern as it is used during animal delivery and milk production, potentially causing reproductive complications and economic loss. The most likely to be affected are farmers, veterinarians, dairy producers, and consumers, due to possible consequences such as reduced food safety, antibiotic residues in milk/meat, and public exposure through the food supply chain.
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.