Pms-pirfenidone 267 & 801 Mg: Data Integrity Concerns With Products Bioequivalence Data That Could Lead To Incorrect Dosing.

Recall Summary PMS-PIRFENIDONE tablets in 267 mg and 801 mg strengths are being recalled across Canada due to data integrity issues with bioequivalence testing that could result in incorrect dosing. This is a Class I recall, indicating a serious quality concern with the drug's effectiveness. The recall affects all patients currently using these specific strengths of this medication.

Product
PMS-PIRFENIDONE 267 & 801 mg
Reason
Product quality
Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DRUGS
Recall date
2024-06-07
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DRUGS

Recall details on Nibble Recalls: https://trynibble.app/recalls/6f251477-eadf-4b7a-80dd-03fca3a7deaa