Sivem Pharmaceuticals ULC Ranitidine Product Recall (2019-10-17)
- Starting date:
- October 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-71357
Last updated: 2019-10-21
Summary
-
Product:
A. Ranitidine 300 mg Tablet;B. Ranitidine 150 mg Tablet
A. Ranitidine 300 mg Tablet;
B. Ranitidine 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. Ranitidine 300 mg Tablet
DIN, NPN, DIN-HIM
DIN 02385961
Dosage form
Tablet
Strength
Ranitidine 300 mg
Lot or serial number
K50941, K50624, K50947, K50950
Companies
- Recalling Firm
-
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent
H4R 2P7
Quebec
CANADA
- Marketing Authorization Holder
-
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent
H4R 2P7
Quebec
CANADA
B. Ranitidine 150 mg Tablet
DIN, NPN, DIN-HIM
DIN 02385953
Dosage form
Tablet
Strength
Ranitidine 150 mg
Lot or serial number
K46484, K50204, K46485, K50206, K50590, K50677, K50908, K48440, K48679, K50207, K50594, K50925, K50928, K50932, K50935, K51080
Companies
- Recalling Firm
-
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent
H4R 2P7
Quebec
CANADA
- Marketing Authorization Holder
-
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent
H4R 2P7
Quebec
CANADA