Recall Alert
| DRAP Alert No | No I/S/04-24-16 |
| Action Date | 28th April 2024 |
| Target Audience | – National Regulatory Field Force. – Points of sale and distributors of veterinary medicine. – Veterinary Doctors and professionals. – General Public |
| Problem / Issue | The Federal Government Analyst, CDL Karachi has declared has declared the following 03 batches of veterinary drug products, manufactured by M/s. Biolabs (Private) Limited, Islamabad as “Adulterated” based on the presence of unaccepted level of Ethylene Glycol and Diethylene Glycol impurities. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Remarks |
|---|---|---|---|
| Clo-Animectin Injection Reg No.095618 | Clorsulon 100mg/ml Ivermectin 10mg/ml | Batch No. 009A24 Mfg. Date: 01-24 Exp. date: 12-25 | Sample is “Adulterated” due to presence of: Ethylene Glycol: 14.36% Diethylene Glycol: 2.92% |
| Bio-Oxicam 0.75% Injection Reg No.088836 | Meloxicam 7.5mg/ml | Batch No. 083C23 Mfg. Date: 03-23 Exp. date: 02-25 | Sample is “Adulterated” due to presence of Ethylene Glycol: 24.19% |
| Bio-E-Floxacin 10% Injection Reg No.088834 | Enrofloxacin 100mg/ml | Batch No. 047K22 Mfg. Date: 10-22 Exp. date: 09-24 | Sample is “Adulterated” due to presence of Ethylene Glycol: 12.08% |
| Risk Statement: | EG (Ethylene Glycol) is a toxic substance that can have serious adverse effects. EG is metabolized into toxic metabolites that can affect the central nervous system, and heart, and can cause kidney damage, which can be fatal. Although, there is no available data on the systemic absorption of injected EG, and no instances of human or animal toxicity from injection of EG have been reported in the literature. |
| Action Initiated | –The manufacturer has been directed to immediately recall the defected batch of product from the market. All personnel working at distributions and point of sales of veterinary medicine should immediately check their stocks and stop supplying this batch of product. The remaining stock should be quarantined and returned to the supplier/ company. Regulatory field force of all federating units (DRAP and Provincial Health Departments) should also increase surveillance in the market to ensure the effective recall of defective products(s). –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 through phone at +92 51 910 73 17, 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 Veterinary Professionals | DRAP requests to enhance vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this defective batch of the product. |