Health product recall

Sandoz Orphenadrine: Impurity

Last updated

Summary

Product
Sandoz Orphenadrine
Issue
Health products - Contamination
What to do
  1. Verify if your product is affected.
  2. Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns.
  3. Contact the recalling firm if you have any questions about the recall.
  4. Report any health product related side effects to Health Canada.
  5. 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:
Alert / recall type
Health product recall
Category
Health products - 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