LAHORE – On the recommendations of Drug Regulatory Authority of Pakistan (DRAP), Punjab government has banned sale of five cough syrups for contamination of diethylene glycol (DEG) and ethylene glycol (EG).
Pharmix Laboratories (Pvt) Ltd, Lahore is selling Mucorid Syrup, Ulcofin Suspension, Alergo syrup, Emidone Suspension and Zincell Syrup in the local market besides exporting to several countries.
DRAP initiated probe after WHO detected presence of DEG/EG impurities in Alergo Syrup exported to Maldives.
Following a preliminary investigation, DRAP has issued a recall of certain batches of these syrups. It also suspected presence of impurities in other batches.
Background:
Between 2022 and 2023, several countries reported incidents of oral liquid drugs that were intended for children and were found to be contaminated with high levels of DEG and EG. These incidents lead to severe adverse events and fatalities in few countries.
Action Initiated:
The manufacturing company has been directed to immediately recall the defective batches of the products from the market. All pharmacists and chemists working at distributions and pharmacies are hereby advised to immediately check their stocks and stop supplying these batches of suspected products. The remaining stock should be quarantined and returned to the supplier/ company. The regulatory field force of DRAP and Provincial Health Departments are also informed regarding the matter and are directed to increase surveillance in the market to ensure the effective recall of defective products.
Advice for Healthcare Professionals:
DRAP requests increased vigilance within the supply chains of institutions/pharmacies/healthcare facilities likely to be affected by this affected batch of products. Adverse reactions or quality problems experienced with the use of this product may be reported to the National Pharmacovigilance Centre (NPC), DRAP using the Adverse Event Reporting Form.
Advice for Consumers/General public:
Consumers should stop using this product bearing the affected batch number(s) and shall contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product, and report the incident to Drug Regulatory Authority of Pakistan/National Pharmacovigilance Centre.
All therapeutic goods must be obtained from the licensed pharmacies, and other authorized retail outlets. The authenticity and condition of products should be carefully checked.
