Sanofi-Aventis Avapro Product Recall(2021-06-14)Health ProductsJun 14th, 2021 @ 12:00 AM
Basic Details
Issue: Product Safety
Category: Drugs
Audience: General Public, Healthcare Professionals, Hospitals
Department: Health Canada
Hazard classification: Type I
Alert type: Drug Recall
Summary
Product
A. Avapro 75mg
Products
| Lot or serial number | Companies | Brand name | DIN, NPN, DIN-HIM | Dosage form | Strength |
|---|---|---|---|---|---|
| ET04153, FT01995, FT01238 |
| B. Avapro 150mg | DIN 02237924 | Tablet | Irbesartan 150 mg |
| FT00969, FT01225, FT01226, FT01999, FT04262 |
| C. Avapro 300mg | DIN 02237925 | Tablet | Irbesartan 300 mg |
| FT00590 |
| A. Avapro 75mg | DIN 02237923 | Tablet | Irbesartan 75 mg |
Reason
Presence of impurity 5-(4-(azidomethyl)-[1,1-biphenyl]-2-yl)-1H-tetrazole above the acceptable concentration
limit in affected lot.
limit in affected lot.
Depth of distribution
Retailers, Other (healthcare practioners)
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