Protriptyline

One lot of APO-Amitriptyline recalled due to a nitrosamine impurity

Retrieved on:

Tuesday, February 7, 2023

Amitriptyline, Patient, NDMA, Risk, Pharmacy, Cancer, Health Canada, Tablet, Protriptyline, Medical device

OTTAWA, ON, Feb. 7, 2023 /CNW/ - Apotex Inc. is recalling one lot of APO-Amitriptyline 10 mg tablets due to the presence of N-nitrosodimethylamine (NDMA), a nitrosamine impurity, above the acceptable limit.

Key Points:

OTTAWA, ON, Feb. 7, 2023 /CNW/ - Apotex Inc. is recalling one lot of APO-Amitriptyline 10 mg tablets due to the presence of N-nitrosodimethylamine (NDMA), a nitrosamine impurity, above the acceptable limit.
Patients should continue taking their amitriptyline drug, as the risks from not having adequate treatment outweigh possible effects of exposure to the levels of NDMA seen in the recalled product.
This means that long-term exposure to a level above what is considered safe may increase the risk of cancer.
Health Canada maintains a list of recalled amitriptyline drugs affected by this issue.

Information Update - Update: Certain lots of Elavil (amitriptyline) and APO-Amitriptyline recalled due to a nitrosamine impurity

Retrieved on:

Wednesday, January 26, 2022

Risk, Protriptyline, Amitriptyline, Cancer, Ciba-Geigy Canada Ltd v Apotex Inc, Health Canada, Patient, Pharmacy, NDMA, Tablet, Medical device

Patients can continue taking their amitriptyline drugs, as the risks from not having adequate treatment outweigh possible effects of exposure to the levels of NDMA seen in the recalled products.

Key Points:

Patients can continue taking their amitriptyline drugs, as the risks from not having adequate treatment outweigh possible effects of exposure to the levels of NDMA seen in the recalled products.
Patients do not need to return their medication to the pharmacy.
Health Canada maintains a list of recalled amitriptyline drugs affected by this issue.
Please see the full advisory for more information, including more on the risk and what patients should do.