Drug Safety Alerts
Attention (ALERT)!
Tablet PHRENNO has been Declared Sub-Standard!
Tablet: PHRENNO (OLANZAPINE 5mg)
Description: Dark pink colored, round tablet with a line of bisection on one side of the tablet, In ALU-ALU pack of 10 units.
Batch No. 6L-839
Manufactured by: Saydon Pharmaceutical Industries (Pvt.) Ltd. 77/A Hayatabad Industrial Estate, Peshawar Pakistan.
Background: Provincial Drug Inspector collected the sample from Punjab Institute of Mental Health (PIMH) Lahore, and sent it to the Punjab Drug Testing Laboratory (DTL) for testing and analysis.
Problem: Manufacturer has claimed dissolution not less than 75% in 30 minutes but DTL found it 51.6% in stated time. On other hand product is labelled orally disintegrating but it is film coated. Therefore, DTL has been declared it SUB-STANDARD and MISBRANDED. This product may be less absorbed & fail to produce desired effect.
Recommendation: This product does not meet appropriate quality standards & 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 medicine.
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