Sivem Pharmaceuticals ULC Ranitidine Product Recall (2019-09-24)
- Starting date:
- September 24, 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-71065
Last updated: 2019-09-25
A. Sivem Ranitidine 150 mg
B. Sivem Ranitidine 300 mg
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. Sivem Ranitidine 150 mg
DIN, NPN, DIN-HIM
DIN 02385953
Dosage form
Tablet
Strength
Ranitidine hydrochloride 150 mg
Lot or serial number
NP4183, NT2757, NT2764, NT2765, PJ2435, NP4184, NT2724, NT2762, NT2763, NP4179, NP5656, NP5657, NT2721, NT2722, PJ2434, PV6243, PV6244, PV6245
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. Sivem Ranitidine 300 mg
DIN, NPN, DIN-HIM
DIN 02385961
Dosage form
Tablet
Strength
Ranitidine hydrochloride 300 mg
Lot or serial number
NP4177, NP4180, NT1365, PX8854
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