Health product recall

AXID (2020-04-29)

Starting date:
April 29, 2020
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-72959



Last updated: 2020-05-04

Summary

  • Product:
    AXID 150 mg Capsules

Reason

Presence of N-nitrosodimethylamine (NDMA) near the interim acceptable concentration limit in affected lots

Depth of distribution

Wholesalers, Retailers, Healthcare establishments

Affected products

AXID 150 mg Capsules

DIN, NPN, DIN-HIM

DIN 00778338

Dosage form

Capsule

Strength

Nizatidine 150 mg

Lot or serial number

616927, 617088

Companies

Recalling Firm

Pendopharm Division of Pharmascience Inc.

SUITE 100 6111, Royalmount Avenue

Montreal

H4P 2T4

Quebec

CANADA

Marketing Authorization Holder

Pendopharm Division of Pharmascience Inc.

SUITE 100 6111, Royalmount Avenue

Montreal

H4P 2T4

Quebec

CANADA