Health product recall

Sandoz Canada Ranitidine Product Recall (2019-09-17)

Starting date:
September 17, 2019
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-71031

Last updated: 2019-09-18

Summary

  • Product:
    A. Sandoz Ranitidine 150 mg Tablet

    B. Sandoz Ranitidine 300 mg Tablet

A. Sandoz Ranitidine 150 mg Tablet

B. Sandoz Ranitidine 300 mg Tablet

Reason

Affected lots may be manufactured with an API containing an impurity, N-nitrosodimethylamine (NDMA).

Depth of distribution

Wholesalers, Retailers

Affected products

A. Sandoz Ranitidine 150 mg Tablet

DIN, NPN, DIN-HIM

DIN 02243229

Dosage form

Tablet

Strength

Ranitidine hydrochloride 150 mg

Lot or serial number

All lots

Companies

Recalling Firm

Sandoz Canada Incorporated

110 Rue De Lauzon

Boucherville

J4B 1E6

Quebec

CANADA

Marketing Authorization Holder

Sandoz Canada Incorporated

110 Rue De Lauzon

Boucherville

J4B 1E6

Quebec

CANADA

B. Sandoz Ranitidine 300 mg Tablet

DIN, NPN, DIN-HIM

DIN 02243230

Dosage form

Tablet

Strength

Ranitidine hydrochloride 300 mg

Lot or serial number

All lots

Companies

Recalling Firm

Sandoz Canada Incorporated

110 Rue De Lauzon

Boucherville

J4B 1E6

Quebec

CANADA

Marketing Authorization Holder

Sandoz Canada Incorporated

110 Rue De Lauzon

Boucherville

J4B 1E6

Quebec

CANADA