APO-Metformin (2020-02-04)

Starting date:
February 4, 2020
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-72281

Last updated:

Summary

  • Product: APO-Metformin 500 mg Tablet

Reason

Presence of N-nitrosodimethylamine (NDMA) above the interim acceptable concentration limit in affected lot(s).

Depth of distribution

Wholesalers, Healthcare Establishments, Retailers

Affected products

APO-Metformin 500 mg Tablet

DIN, NPN, DIN-HIM

DIN 02305062

Dosage form

Tablet (Extended-Release)

Strength

Metformin Chlorohydrate 500 mg

Lot or serial number

NV3242, NV3244, NV3245, NV3243, NV3247, NV3248, PX5334, PX5335

Companies

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