Sanis Health Inc. 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-71081
Last updated: 2019-09-26
A. Ranitidine
B. Ranitidine
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
DIN, NPN, DIN-HIM
DIN 02353016
Dosage form
Tablet
Strength
Ranitidine hydrochloride 150mg
Lot or serial number
All lots
Companies
- Recalling Firm
-
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA
- Marketing Authorization Holder
-
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA
B. Ranitidine
DIN, NPN, DIN-HIM
DIN 02353024
Dosage form
Tablet
Strength
Ranitidine hydrochloride 300mg
Lot or serial number
All lots
Companies
- Recalling Firm
-
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA
- Marketing Authorization Holder
-
Sanis Health Inc.
1 President’s Choice Circle,
Brampton
L6Y 5S5
Ontario
CANADA