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dom-Pantoprazole (2014-04-04)
- Starting date:
- April 4, 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-38887
Recalled Products
dom-Pantoprazole
Reason
A dissolution test revealed out-of-specification results. An in-depth investigation showed that dissolution took 90 minutes instead of 45, as indicated in the product specifications.
Depth of distribution
Wholesalers and Pharmacies in Canada.
Affected products
dom-Pantoprazole
DIN, NPN, DIN-HIM
DIN 02310007
Dosage form
Delayed release tablets
Strength
40 mg
Lot or serial number
C304419
Companies
- Recalling Firm
-
Pharmapar
5950 Côte de Liesse
Mount Royal
H4T 1E2
Quebec
CANADA
- Marketing Authorization Holder
-
Dominion Pharmacal
100 - 6111 Royalmount Ave.
Montreal
H4P 2T4
Quebec
CANADA