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: 2021-04-15
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 02047535Dosage 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