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

MONTREAL, Jan. 25, 2022 /CNW/ - AA Pharma Inc. is recalling two lots of Elavil (amitriptyline) (lots PY1829 and PY1830) and Apotex Inc. is recalling one additional lot of APO-Amitriptyline (lot PY1832) 10 mg tablets due to the presence of NDMA, a nitrosamine impurity, above the acceptable limit. 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.

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 or Elavil (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
AA Pharma Inc.	Elavil (Amitriptyline Hydrochloride Tablets USP)	10 mg	00335053	PY1829	12/2023
AA Pharma Inc.	Elavil (Amitriptyline Hydrochloride Tablets USP)	10 mg	00335053	PY1830	12/2023
Apotex Inc.	APO-Amitriptyline (Amitriptyline Hydrochloride Tablets USP)	10 mg	02403137	PY1832	12/2023

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SOURCE Health Canada

Media Inquiries: Health Canada, [phone], [email protected]; Public Inquiries: [phone], 1-866 225-0709, [email protected]