Drug Safety Alerts
Attention (ALERT)!
Syrup DENOL-DM has been Declared SUB-STANDARD!
Syrup: DENOL-DM (DEXTROMETHORPHAN HBR 10MG/5ML, PSEUDOEPHEDRINE HCI 20MG/5ML, CHLORPHENAMINE MALEATE 2MG/5ML).
Description: Pink Liquid in Amber Glass Bottle with Sealed Screw Cap.
Batch No. 10370
Manufactured by: Novamed Pharmaceuticals (Pvt) Ltd., 28-Km, Ferozepur Road, Lahore.
Background: Provincial Drug Inspector collected the sample from Nashtar Town, Lahore, and sent it to the Punjab Drug Testing Laboratory (DTL) for testing and analysis.
Problem: Manufacturer has claimed that PSEUDOEPHEDRINE 20mg/5ml. But the DTL has determined PSEUDOEPHEDRINE 16.02mg/5ml (80.1%) that does not comply the stated specifications. Therefore, DTL has been declared it SUB-STANDARD.
Recommendation: This product does not meet appropriate quality standards and specifications and may therefore, be ineffective and potentially harmful to patients. All concerned are intimated to keep caution in procurement, dispensation, promotion and use of this pharmaceutical product.
Note. Healthcare professionals and consumers are encouraged to report adverse events or side effects related to the use of any pharmaceutical product to Provincial Drugs Control Unit Punjab through mentioned URL: mss.punjab.gov.pk/reporttgrp
Primary & Secondary Healthcare Department,
Govt. of the Punjab