APO-AMITRIPTYLINE Tablets: NNORT impurity
Last updated
Summary
Product
APO-AMITRIPTYLINE Tablets
Issue
Health products - Contamination
What to do
Consult your health care professional if you have any health concerns.
Affected products
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot |
|---|---|---|---|---|---|
Apotex |
APO-AMITRIPTYLINE 10 mg |
DIN 02403137 |
Tablet |
AMITRIPTYLINE HYDROCHLORIDE 10 MG |
PY1833, RM0518 |
Apotex |
APO-AMITRIPTYLINE 25 mg |
DIN 02403145 |
Tablet |
AMITRIPTYLINE HYDROCHLORIDE 25 MG |
PV0569 |
Issue
Affected lots exceed the interim acceptable intake limit for N-nitroso-nortriptyline (NNORT).
What you should do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Additional information
Background
Depth of recall: Wholesalers, Retailers, Healthcare establishments
Details
Original published date: 2023-08-14
Alert / recall type
Health product recall
Category
Health products - Drugs
Companies
Apotex Inc
150 Signet Drive, Toronto
ON, M9L 1T9
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type I
Identification number
RA-74114