PMS-AMITRIPTYLINE 10 mg, 25 mg, and 50 mg: NDMA and NNORT impurity
Summary
Consult your health care professional if you have any health concerns.
Affected products
Brand |
Product Name |
Market Authorization |
Dosage Form |
Strength |
Lot |
|---|---|---|---|---|---|
PMS-AMITRIPTYLINE 10 mg |
PMS-AMITRIPTYLINE 10 mg |
DIN 00654523 |
Tablet |
Amitriptyline Chlorhydrate 10 mg |
635484 |
PMS-AMITRIPTYLINE 25 mg |
PMS-AMITRIPTYLINE 25 mg |
DIN 00654515 |
Tablet |
Amitriptyline Chlorhydrate 25 mg |
635435 |
PMS-AMITRIPTYLINE 50 mg |
PMS-AMITRIPTYLINE 50 mg |
DIN 00654507 |
Tablet |
Amitriptyline Chlorhydrate 50 mg |
634972 |
Issue
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).
What you should do
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.
Additional information
Background
Depth of recall: Retailers
Details
Pharmascience Inc.
6111 Avenue Royalmount, Montréal
Québec, H4P 2T4
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