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Health product recall

Pantoprazole (2015-12-17)

Starting date:
December 17, 2015
Posting date:
January 7, 2016
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-56528

Affected Products

Pantoprazole

Reason

Recall conducted because the dissolution testing performed for this lot as part of the stability study at the18-month interval does not meet the specifications.

Depth of distribution

Wholesalers and pharmacies in Quebec

Affected products

Pantoprazole

DIN, NPN, DIN-HIM
DIN 02318695
Dosage form

Tablet (Delayed-Release)

Strength

40 mg

Lot or serial number

KW6127

Companies
Recalling Firm
Pro Doc Ltd.
2925 Industrial Blvd.
Laval
H7L 3W9
Quebec
CANADA
Marketing Authorization Holder
Pro Doc Ltd.
2925 Industrial Blvd.
Laval
H7L 3W9
Quebec
CANADA