112. Recall Alert (Class-I) – Veterinary Drug Products (Substamdard)

VETERINARY DRUG PRODUCTS DECLARED SUBSTANDARD BY PROVINCIAL DRUG LABORATORIES, KARACHI.

DRAP Alert No	No I/S/10-25-111
Action Date	18 November, 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 Drug products have been declared as ‘Substandard ’.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1.	Injection Antil 50 ml Each ml Contains: Pheniramine maleate …… 11.35mg (Reg. # 074750)	AN-2520 & AN-2519	M/s Izfaar Pharmaceutical Industries.   542/A-B Sunder Industrial Estate Lahore (DML # 000800)	The sample is declared as “Sub-Standard” on the basis of Assay Test and Sterility Test.
2.	Injection Mac Rold 2% 50 ml Each ml contains: Ivermectin …. 20 mg (Reg # 106810)	YI-140	M/s Haarlods Pharmaceuticals (Pvt) Ltd. Plot No.60-64/C, Small Industrial Estate, Bhimber, AJK. (DML # 000921)	The sample is declared as “Sub-Standard” on the basis of Assay Test and Related substances.

Risk Statement:	The above veterinary injectable products have been declared Substandard on the basis of critical quality failures, including Assay, Chromatographic Purity/Related Substances, and Sterility tests. Use of such defective veterinary injections poses a significant risk of treatment failure, toxicity, adverse reactions, and severe infections in animals. The groups most likely to be affected include livestock farmers, dairy producers, animal handlers, and veterinarians, as compromised product quality may lead to animal morbidity or mortality, reduced productivity, contamination of milk or meat, and consequential economic losses. These defects may also indirectly impact public health, particularly where contaminated or inadequately treated animals enter 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, livestock owners, and veterinary practitioners are advised not to use the affected batches of the above-mentioned injectable veterinary products found Substandard due to failures in Assay, Sterility, Chromatographic Purity, and Related Substances tests. Use of such defective injections may result in ineffective treatment, unexpected adverse reactions, infections, toxicity, or deterioration in the animal’s health and productivity. Immediately stop administration, isolate remaining stock, and return it to your supplier or distributor. If any animal has already received these injections, monitor for unusual symptoms such as fever, swelling at the injection site, allergic reactions, or treatment failure, and consult a qualified veterinarian without delay. Livestock handlers, dairy owners, and farmers are further advised to ensure that only quality-assured and properly stored veterinary medicines are used for animals to protect herd health, avoid economic loss, and prevent contamination of milk and meat entering the food chain.