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Health product recall

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

Date modified: