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 02385961Dosage 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 02385953Dosage 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