PMS-AMITRIPTYLINE 10 mg, 25 mg, and 50 mg: NDMA and NNORT impurity

Affected lots exceed the interim acceptable intake limit for N-nitroso-nortriptyline (NNORT) or exceed the acceptable cumulative intake limit for (N-nitrosodimethylamine (NDMA) and NNORT).

Contamination

Continue taking your medication . Not treating a condition may pose a greater health risk than potential nitrosamine exposure. Contact your health care provider: to discuss treatment options if you're using a recalled product if you have taken a recalled product and are concerned about your health Ask your pharmacist if you're not sure if the product you're taking has been recalled.

PMS-AMITRIPTYLINE 10 mg, 25 mg, and 50 mg

RA-74145