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pms-Pantoprazole (2014-04-01)
- Starting date:
- April 1, 2014
- Posting date:
- April 8, 2014
- Type of communication:
- Drug Recall
- Subcategory:
- Drugs
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Product Safety
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38889
Recalled Products
pms-Pantoprazole
Reason
These batches were recalled following out-of-specification dissolution test results. An investigation revealed that dissolution took 90 minutes instead the 45 minutes indicated in the product specifications.
Depth of distribution
Wholesalers and Pharmacies in Canada.
Affected products
pms-Pantoprazole
DIN, NPN, DIN-HIM
DIN 02307871
Dosage form
Delayed release tablets
Strength
40 mg
Lot or serial number
C304418
C304420
C304421
Companies
- Recalling Firm
-
Pharmascience Inc.
100 - 6111 Royalmount Ave.
Montreal
H4P 2T4
Quebec
CANADA
- Marketing Authorization Holder
-
Pharmascience Inc.
100 - 6111 Royalmount Ave.
Montreal
H4P 2T4
Quebec
CANADA