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: 2020-02-04
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