APO-AMITRIPTYLINE 10mg (2021-04-29)
- Starting date:
- April 29, 2021
- 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-75519
Last updated:
2021-04-30
Summary
-
Product:
APO-AMITRIPTYLINE 10mg
Reason
Presence of higher than accepted levels of a nitrosamine impurity known as N-nitrosodimethylamine (NDMA) in the affected lot.
Depth of distribution
Retailers, Wholesalers, Healthcare Establishments
Affected products
APO-AMITRIPTYLINE
DIN, NPN, DIN-HIM
DIN 02403137
Dosage form
Tablet
Strength
AMITRIPTYLINE HYDROCHLORIDE 10mg
Lot or serial number
PY1831
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