Health product recall

Apo-Amitriptyline: Affected lots may exceed the interim acceptable intake limit for NNORT

Brand(s)
Last updated

Summary

Product
Apo-Amitriptyline
Issue
Health products - Product safety
What to do

Consult your health care professional if you have any health concerns.

Distribution
Alberta
British Columbia
Manitoba
Newfoundland and Labrador
Nova Scotia
Ontario
Quebec
Saskatchewan

Affected products

Brand

Product Name

Market Authorization

Dosage Form

Strength

Lot

Apo

Apo-Amitriptyline

DIN 02403137

Tablet

Amitriptyline Hydrochloride 10 mg

RN6384, RR0265, RR0266, RV1644, RV1645, RW8597, RW8598, TA6008, TA6009, TF8585, TF8586, TF8587, TF8588, TF8589, TW2842, TW2843

Apo

Apo-Amitriptyline

DIN 02403145

Tablet

Amitriptyline Hydrochloride 25 mg

RM0519, RM8130, RR0780, RR0781, RV1656, RV1657, RW8691, TA6061, TA6062, TF8602, TF8603

Issue

Affected lots exceed or may exceed the interim acceptable intake limit for N-nitroso-nortriptyline (NNORT)

What you should do

  1. Verify if your product is affected.
  2. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
  3. Contact the recalling firm if you have any questions about the recall.
  4. Report any health product related side effects to Health Canada.
  5. Report any other health product safety complaints to Health Canada.

Additional information

Previous recalls or alerts
Background

Depth of recall: Wholesalers, Retailers, Healthcare Establishments

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies

Apotex Inc

150 Signet Drive, Toronto, ON Canada M9L 1T9

Published by
Health Canada
Audience
General public
Healthcare
Industry
Distribution
Alberta
British Columbia
Manitoba
Newfoundland and Labrador
Nova Scotia
Ontario
Quebec
Saskatchewan
Recall class
Type I
Identification number
RA-76352

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