Drug Safety Alerts
ATTENTION (ALERT)!
Tablet DILZEM has been declared SUB-STANDARD!
Tablet: DILZEM (Diltiazem HCL 30mg)
Batch No. 1725003
Manufactured by: Pfizer Pakistan Ltd. Karachi, Pakistan
Background: Provincial Drug Inspector collected the sample from Central Medical Store Depot Lahore and sent it to the Punjab Drug Testing Laboratory (DTL) for testing and analysis.
Problem: Manufacturer has claimed dissolution NMT 60% of the labelled amount of diltiazem in 30 min & NLT 75% in 3 hrs. But DTL has determined out of specification values for both above mentioned limits. Therefore, Punjab Drug Testing Laboratory has declared it SUB-STANDARD. Product may show fluctuations in drug absorption and may fail to produce desired effects.
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