Apotex 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-71079
Last updated: 2019-09-26
A. Selection Acid Reducer
B. Equate Acid Reducer
C. APO-Ranitidine Tablet 150mg
D. APO-Ranitidine Tablet 300mg
E. APO-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. Selection Acid Reducer
DIN, NPN, DIN-HIM
DIN 02296160
Dosage form
Tablet
Strength
Ranitidine hydrochloride 150mg
Lot or serial number
All lots
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
B. Equate Acid Reducer
DIN, NPN, DIN-HIM
DIN 02296160
Dosage form
Tablet
Strength
Ranitidine hydrochloride 150mg
Lot or serial number
All lots
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
C. APO-Ranitidine Tablet 150mg
DIN, NPN, DIN-HIM
DIN 00733059
Dosage form
Tablet
Strength
Ranitidine hydrochloride 150mg
Lot or serial number
All lots
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
D. APO-Ranitidine Tablet 300mg
DIN, NPN, DIN-HIM
DIN 00733067
Dosage form
Tablet
Strength
Ranitidine hydrochloride 300mg
Lot or serial number
All lots
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
E. APO-Ranitidine
DIN, NPN, DIN-HIM
DIN 02280833
Dosage form
Solution
Strength
APO-Ranitidine Solution 75mg/5ml
Lot or serial number
All lots
Companies
- Recalling Firm
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA
- Marketing Authorization Holder
-
Apotex Inc.
150 Signet Drive
Toronto
M9L 1T9
Ontario
CANADA