Rapid Alert: Recall of Contaminated Liquid Preparations

DRAP Alert No	No I/S/09-24-33
Action Date	10th 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 of Ethylene Glycol in following liquid preparations. Drug Testing Laboratories (DTLs) have declared these batches of products as Substandard based on their analysis which revealed the presence of Ethylene Glycol exceeding limits. T

Therapeutic Good(s) Affected: –

The details of the affected batches are as follows:

S#	Product Name	Composition	Batch No.	Manufactured by
01	Texcol EX Syrup 120ml   Reg. No. 030897	Aceylline Piperazine 45mg/5ml, Diphenhydramine HCl 8mg/5ml	63864	M/s. Razee Therapeutics (Pvt.) Ltd., Lahore
02	Speczine Syrup 120ml   Reg. No. 012597	Promethazine HCl 5mg/5ml	609 604 YZ	M/s. Spectrum Laboratories, Lahore
03	Mexair Syrup 60ml   Reg. No. 02665	Terbutaline Sulphate 1.5mg/5ml	05-23 02-22	M/s. Siza Int., Lahore
04	Stazin Syrup 60ml   Reg. no. 026326	Cetrizine HCl 5mg/5ml	GI 83	M/s. Munawar Pharma (Pvt.) Ltd., Lahore
05	Zevirol Expectorant syrup 120ml Reg. No. 009378	Dipenhydramine HCl 13.5mg, Ammonium Chloride 131.5mg, sodium citrate 55mg, Menthol 1mg	4031	P.D.H. Laboratories Lahore

06	Stazin Syrup 60ml   Reg. No. 026326	Cetrizine HCl 5mg/5ml	GI83	M/s. Munawar Pharma Lahore
07	Zevirol Expectorant syrup 120ml   Reg. No. 009.78	Diphenhydramine 13.5mg, Ammonium Choride 131.5mg	4031	M/s. P.D.H. Pharmaceuticals Lahore
08	Aphylin Expectorant Syrup   Reg. No. 026635	Aminophylline 32mg/5ml, Diphenhydramine 8mg/5ml, Amonium Chloride 30mg/5ml	24C090	M/s. Obsons Pharmaceuticals Lahore
09	Resfyl Syrup   Reg. No. 057214	Acefylline Piperzine 45mg/5ml, Diphenhydramine 8mg/5ml	4A055	M/s. Rasco Pharma Lahore
10	Zonid Suspension 120ml   Reg. No. 022579	Metronidazole 200mg/5ml	Z492 Z246	M/s. Bloom Pharmaceuticals Hattar
11	Butamin Syrup 60ml   Reg. No. 016630	Salbutamol 2mg	4016	M/s. P.D.H Pharmaceuticals, Lahore
12	Nuocid Plus suspension 120ml   Enlst. No. 0327660558	Zingiber Officinale 20mg/5ml, Mentha Piperita 40mg/5ml	NC-S045	M/s. Arber Pharma Lahore

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	-The manufacturers of products have been directed to immediately recall the defective batches of from the market. 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.