Orfenace Tablet 100mg(2021-04-13)

Starting date:
April 13, 2021
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75399

Last updated:

Summary

  • Product: Orfenace Tablets 100mg

Reason

Presence of N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine (NMOA) above the acceptable concentration limit in affected lots.

Depth of distribution

Retailers, Wholesalers

Affected products

Orfenace Tablet 100mg

DIN, NPN, DIN-HIM

DIN 02047535

Dosage form

Tablet

Strength

Orphenadrine Citrate 100mg

Lot or serial number

10025A18,10025B18,10025A19,36664, 37342,37384,38058

Companies

Recalling Firm
Sterimax Inc.
2770 Portland Drive
Oakville
L6H 6R4
Ontario
CANADA
Marketing Authorization Holder
Sterimax Inc.
2770 Portland Drive
Oakville
L6H 6R4
Ontario
CANADA