APO-Metformin (2020-06-12)
Health Products
Jun 12th, 2020 @ 12:00 AM

Basic Details

Issue: Product Safety
Category: Drugs
Audience: General Public, Healthcare Professionals, Hospitals
Department: Health Canada
Alert type: Drug Recall
Hazard classification: Type I

Summary

Product

APO-Metformin 500 mg Extended Release Tablet

Products

Lot or serial numberCompaniesBrand nameDIN, NPN, DIN-HIMDosage formStrength
PK3968
Recalling Firm
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
Marketing Authorization Holder
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
APO-Metformin 500 mg Extended Release TabletDIN 02305062Tablet (Extended Release)Metformin hydrochloride 500 mg

Reason

Affected lots contain or may contain the presence of N-nitrosodimethylamine (NDMA) above the interim acceptable concentration limit.

Depth of distribution

Wholesalers, Retailers

For more information

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