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:

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