Sanofi Consumer Health Zantac Product Recall (2019-10-18)

Starting date:
October 18, 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-71399

Last updated:

Summary

  • Product:
    1. Zantac 75 mg Tablet;
    2. Zantac 150 mg Tablet
  1. Zantac 75 mg Tablet;
  2. Zantac 150 mg Tablet

Reason

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

Depth of distribution

Wholesalers, Healthcare Establishments, Retailers

Affected products

A.  Zantac 75 mg Tablet

DIN, NPN, DIN-HIM

DIN 02230287

Dosage form

Tablet

Strength

Ranitidine 75 mg

Lot or serial number

All lots

Companies

Recalling Firm
Sanofi Consumer Health Inc.
2905 Place Louis-R-Renaud
Laval
H7V 0A3
Quebec
CANADA
Marketing Authorization Holder
Sanofi Consumer Health Inc.
2905 Place Louis-R-Renaud
Laval
H7V 0A3
Quebec
CANADA

B.  Zantac 150 mg Tablet

DIN, NPN, DIN-HIM

DIN 02277301

Dosage form

Tablet

Strength

Ranitidine 150 mg

Lot or serial number

All lots

Companies

Recalling Firm
Sanofi Consumer Health Inc.
2905 Place Louis-R-Renaud
Laval
H7V 0A3
Quebec
CANADA
Marketing Authorization Holder
Sanofi Consumer Health Inc.
2905 Place Louis-R-Renaud
Laval
H7V 0A3
Quebec
CANADA