Drug Safety Alerts
ATTENTION (ALERT)!
Tablet CALAMOX has been declared SUB-STANDARD!
Tablet: CALAMOX (AMOXICILLIN 500MG; CLAVULANIC ACID 125MG)
Description: White coloured Elliptical film-coated tablet in ALU-ALU Packing.
Batch No. C17747
Manufactured by: Bosch Pharmaceuticals (Pvt.) Ltd. Karachi, Pakistan
Background: Provincial Drug Inspector collected the sample from Govt. Nawaz Sharif Teaching Hospital, Lahore and sent it to the Punjab Drug Testing Laboratory (DTL) for testing and analysis.
Problem: Manufacturer has claimed Clavulanic Acid 125mg/tab. But the DTL has determined Clavulanic Acid 94.47mg (75.6%)/tab which does not comply the stated specifications. Therefore, DTL has declared it SUB-STANDARD. This product will fail to produce required therapeutic effect.
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 avoid 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