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

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. Patients do not need to return their medication to the pharmacy.

NDMA is classified as a probable human carcinogen. This means that long-term exposure to a level above what is considered safe may increase the risk of cancer. Health Canada is advising that there is no immediate risk in continuing to take the recalled APO-Amitriptyline  since the potential risk of cancer is with long-term exposure (every day for 70 years) to NDMA that exceeds safe levels. 

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.

Affected Products

Company	Product	Strength	DIN	Lot	Expiry
Apotex Inc.	APO-Amitriptyline (Amitriptyline Hydrochloride Tablets USP)	10 mg	02403137	PY1904	12/2023

SOURCE Health Canada

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