Recall Alert
| DRAP Alert No | No I/S/04-24-18 |
| Action Date | 29th April 2024 |
| Target Audience | – National Regulatory Field Force. – Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores – Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospital and clinics – General Public |
| Problem / Issue | The Federal Government Analyst, CDL Karachi has declared the following batches of oral liquid preparations manufactured by M/s Biolab Pvt Ltd, Islamabad as of “Sub-standard” quality based on the presence of Ethylene Glycol impurity at an unacceptable level. |
Therapeutic Good(s) Affected: –
| Product Names | Composition | Batch No | Manufactured by |
|---|---|---|---|
| Mebzole 100mg/5mL Suspension Reg No. 046308 | Mebendazole | Batch No. 22J022(F), 22J022(B) Mfg. Date: 09-22 Exp. date: 08-24 | M/s. Biolabs (Private.) Limited., Islamabad. |
| Bioris 1mg/ml Oral Solution Reg No. 069917 | Risperidone | Batch No. 23B061 Mfg. Date: 02-23 Exp. date: 01-25 | M/s. Biolabs (Private.) Limited., Islamabad. |
| Risk Statement: | The presence of Ethylene Glycol (EG) in oral liquid preparations poses serious health risks due to its toxicity as small amounts of EG can be fatal, especially for children. When ingested, both diethylene glycol (DEG) and EG are metabolized into toxic compounds that can adversely affect the central nervous system, heart, and kidneys. |
| Action Initiated | –The manufacturer has been directed to immediately recall the defective batches of affected products from the market. All pharmacists and chemists working at distributions and pharmacies should immediately check their stocks and stop supplying these batches of products. –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 Healthcare 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. -Adverse reactions or quality problems experienced with this product may be reported to the National Pharmacovigilance Centre(NPC), DRAP using the Adverse Event Reporting Form or online through this link. -Please click here for further information on problem reporting to DRAP. |
| Advice for Consumers | -Consumers should stop using these product bearing the affected batch number(s). They shall contact their physician or healthcare provider(s) if they have experienced any problem that may be related to using this product. -All therapeutic products must be obtained from authorized licensed pharmacies /outlets. Their authenticity and condition should be carefully checked. If you have any doubts, please seek advice from your pharmacist. |