APO-Metformin (2020-06-12)

Starting date:
June 12, 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-73339

Last updated:

Summary

  • Product: APO-Metformin 500 mg Extended Release Tablet

Reason

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

Depth of distribution

Wholesalers, Retailers

Affected products

APO-Metformin 500 mg Extended Release Tablet

DIN, NPN, DIN-HIM

DIN 02305062

Dosage form

Tablet (Extended Release)

Strength

Metformin hydrochloride 500 mg

Lot or serial number

  • PK3968
  • PK3969
  • PX5336
  • PY7174
  • PY7175
  • RF6463
  • RF6464
  • RF6465
  • RF6466

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