Sandoz Orphenadrine: Impurity
Last updated
Summary
Product
Sandoz Orphenadrine
Issue
Health products - Contamination
What to do
- Verify if your product is affected.
- Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
- Contact the recalling firm if you have any questions about the recall.
- Report any health product related side effects to Health Canada.
- Report any other health product safety complaints to Health Canada.
Audience
Health professionals
Affected products
Brand |
Produce Name |
Market Authorization |
Dosage Form |
Strength |
Lot |
|---|---|---|---|---|---|
Sandoz |
Sandoz Orphenadrine |
DIN 02243559 |
Tablet (Extended-Release) |
Orphenadrine Citrate 100mg |
JY6254, JY6255 |
Issue
| Presence of impurity N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine (NMOA) above the acceptable concentration limit in affected lots. |
Additional information
Background
Depth of Recall: Retailers
Details
Original published date: 2021-11-03
Alert / recall type
Health product recall
Category
Health product - Drugs
Companies
|
Sandoz Canada Inc 110 de Lauzon Boucherville, Quebec, J4B 1E6 |
Published by
Health Canada
Audience
Health professionals
Recall class
Type II
Identification number
RA-63537