Drug Safety Alerts
ATTENTION (ALERT)!
Eye Drops OPHTH-BIOVISC has been declared SUB-STANDARD!
Eye Drops: OPHTH-BIOVISC (Hydroxypropyl Methylcellulose: 2% w/v)
Description: Colourless liquid packed in glass vial having aluminium seal and blue flip-off cap.
Batch No. 347
Manufactured by: Ophth Pharma (Pvt.) Ltd. Karachi, Pakistan
Background: Provincial Drug Inspector collected the sample from Mayo Hospital Lahore and sent it to the Punjab Drug Testing Laboratory (DTL) for testing and analysis.
Problem: Manufacturer has claimed Hydroxypropyl Methylcellulose 20mg/ml. But the DTL has determined 15.96mg (79.8%)/ml 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, sale 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