104. Recall Alert – Veterinary Drug Products Declared Substandard.

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

DRAP Alert No	No I/S/10-25-104
Action Date	30 October, 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 products have been declared as ‘Substandard / Misbranded’.

Therapeutic Goods (s) Affected: –

S#	Product Details	Batch #	Manufacturer details	Remarks
1.	Inj. Genta-Combisone 50ml   Each 100 ml contains: Tylosin Tartrate………. 15 gm Gentamicin Sulphate ….6 gm Dexamethasone ……0.0265 gm Chlorpheniramine…. 0.750 gm (Reg # 046696)	GC-168	M/s Leads Pharma (Pvt) Ltd. Plot No. 81-A Street No. 6 I-10/3 Islamabad. (DML # 000392)	The sample is Sub-Standard with regards to Sterility Test.
2.	Injection Ivergen 10ml Each ml contains: Ivermectin………10 mg (Reg. # 023432)	594.IV	M/s Symans Pharmaceuticals (Pvt) Ltd. 10-Km Sheikhupura Road Lahore. (DML # 000323)	The sample is Sub-Standard with regards to Assay and Test for related substances.

Risk Statement:	The use of these defective veterinary injectable products may adversely affect livestock and farm animals, particularly those treated for infections or parasitic infestations. Injection Genta-Combisone poses a risk of microbial contamination due to sterility failure, which can lead to abscesses, septicemia, and reduced milk or meat yield in cattle, buffalo, goats, and other farm species. Injection Ivergen, being sub-standard in assay and related substances, may result in incomplete parasite control, therapeutic failure, and possible drug resistance in treated herds. These defects ultimately endanger the health and productivity of livestock, causing economic losses to farmers and potentially impacting the safety of animal-derived food products consumed by the general public.
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 not to use the affected batches of Injection Genta-Combisone (Batch # GC-168) and Injection Ivergen (Batch # 594.IV) on their animals. The use of non-sterile or sub-standard veterinary injections can cause serious illness, swelling, infection, or treatment failure in cattle, buffalo, goats, and other livestock. If any animals have recently been treated with these products and show signs of fever, swelling at the injection site, weakness, or loss of appetite, stop using the product immediately and consult a qualified veterinarian. Farmers should return the remaining stock to the supplier, distributor, or the nearest veterinary office. They are further advised to purchase veterinary medicines only from authorized dealers and ensure that the products bear clear batch numbers, expiry dates, and registration details issued by DRAP. For continued livestock health and to avoid losses, always store veterinary medicines properly, follow veterinary guidance for dosage, and report any suspected quality-related issues to the Provincial Livestock Department or DRAP through the official complaint channels.