Orfenace Tablet 100mg(2021-04-13) | Recall Monitor

Orfenace Tablet 100mg(2021-04-13)
Health Products
Apr 13th, 2021 @ 12:00 AM

Basic Details

Category: Drugs
Issue: Product Safety
Audience: General Public, Healthcare Professionals, Hospitals
Department: Health Canada
Alert type: Drug Recall
Hazard classification: Type I

Summary

Product

Orfenace Tablets 100mg

Products

Lot or serial numberBrand nameCompaniesDIN, NPN, DIN-HIMDosage formStrength
10025A18,10025B18,10025A19,36664, 37342,37384,38058Orfenace Tablet 100mg
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
DIN 02047535TabletOrphenadrine Citrate 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

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