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: 2020-06-13
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