Pharmascience Inc. Ranitidine Product Recall (2019-10-23)
- Starting date:
- October 23, 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-71419
Last updated: 2019-10-25
- Acid Reducer 75mg
- Acid Reducer 150mg
- Maximum Strength Acid Reducer Without Prescription 150mg
- PMS-Ranitidine 150mg
- PMS-Ranitidine 300mg
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. Acid Reducer 75mg
DIN, NPN, DIN-HIM
DIN 02247551
Dosage form
Tablet
Strength
Ranitidine hydrochloride 75mg
Lot or serial number
All lots
Companies
- Recalling Firm
-
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA
- Marketing Authorization Holder
-
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA
B. Acid Reducer 150mg
DIN, NPN, DIN-HIM
DIN 02400103
Dosage form
Tablet
Strength
Ranitidine hydrochloride 150mg
Lot or serial number
All lots
Companies
- Recalling Firm
-
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA
- Marketing Authorization Holder
-
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA
C. Maximum Strength Acid Reducer Without Prescription 150mg
DIN, NPN, DIN-HIM
DIN 02293471
Dosage form
Tablet
Strength
Ranitidine hydrochloride 150mg
Lot or serial number
All lots
Companies
- Recalling Firm
-
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA
- Marketing Authorization Holder
-
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA
D. PMS-Ranitidine 150mg
DIN, NPN, DIN-HIM
DIN 02242453
Dosage form
Tablet
Strength
Ranitidine hydrochloride 150mg
Lot or serial number
All lots
Companies
- Recalling Firm
-
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA
- Marketing Authorization Holder
-
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA
E. PMS-Ranitidine 300mg
DIN, NPN, DIN-HIM
DIN 02242454
Dosage form
Tablet
Strength
Ranitidine hydrochloride 300mg
Lot or serial number
All lots
Companies
- Recalling Firm
-
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA
- Marketing Authorization Holder
-
Pharmascience Inc.
100, 6111 Royalmount Avenue
Montréal
H4P 2T4
Quebec
CANADA