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Health product recall

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

Date modified: