Rapid Alert: Recall of Contaminated Liquid Preparations

DRAP Alert No	No I/S/09-24-32
Action Date	06th September 2024
Target Audience	·  Pharmacists and Chemists at Distribution, Pharmacies and Medical Stores ·  Healthcare Professionals- Physicians, Pharmacists, and Nurses at hospitals and clinics etc. · General Public
Problem / Issue	The Directorate of Drugs Control (DDC), Punjab has identified contamination with ethylene glycol and diethylene glycol in the following liquid preparations. Analysis from Drug Testing Laboratories (DTLs) has declared these products as Substandard

Therapeutic Good(s) Affected: –

The details of the affected batches are as follows:

S#	Product Name	Composition	Batch No.	Manufactured by
01	Cestonil Plus syrup   Reg. No. 021843	Thiamine 1.75mg, Riboflavin 2.62mg, Pyridoxine 1.54mg, Nicotinamide 10.50mg	061357	M/s. Razzee Therapeutics, Lahore
02	Texcol DM 10mg/5ml syrup   Reg. No. 025034	Dextromethorphan	09980	M/s. Razzee Therapeutics, Lahore
03	Speczine 5mg/5ml Syrup   Reg. No. 012597	Promethazine	280 287	M/s. Spectrum Laboratories, Lahore
04	Aphylin Syrup   Reg. No. 026635	Aminophylline 32mg, Diphenhydramine 8mg, Ammonium HCl 30mg	24B056	M/s. Obsons Pharmaceuticals, Lahore
05	Zolint Suspension   Reg. No. 016494	Furazolidone 25mg/5ml, Metronidazole 75mg/5ml	24003	M/s. Libra Private Ltd., Peshawar

Risk Statement	Di-ethylene Glycol (DEG) and Ethylene Glycol (EG) contaminated oral preparations can lead to serious health risks. When ingested, EG and DEG are converted into toxic metabolites that can affect the central nervous system and heart. Moreover, it can also cause kidney damage which may lead to fatal consequences
Action Initiated	-All pharmacists and chemists working at distributions 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 through phone at +92 51 910 73 17, or by Email at gsms∂dra.gov.pk. -The 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 these defective batches of liquid products.   -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 this 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.