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:
2019-10-23
Summary
-
Product:
- Zantac 75 mg Tablet;
- Zantac 150 mg Tablet
- Zantac 75 mg Tablet;
- 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
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