Health Canada Safety Recall - NMOA

[Naiffer_Host]

The nitrosamine impurity found in OrfenAce is called NMOA (N-methyl-N-nitroso-2-[(2 methylphenyl) phenylmethoxy]ethanamine)

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75405a-eng.php

[Naiffer_Host]

April 29, 2021 – Second lot of antidepressant (Amitriptyline) recalled due to presence of nitrosamine impurity

https://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75413a-eng.php

[Yosukemino]

I add the image of NMOA and API.

NMOA

API of OrfenAce

[Yosukemino]

I add the image of NDMA and API.

NDMA

Amitriptyline Hydrochloride