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Health product recall

Pantoprazole (2013-12-11)

Starting date:
December 11, 2013
Posting date:
January 13, 2014
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-37391

Recalled products

  1. Pantoprazole 

Reason

The firm Sivem Pharmaceuticals ULC was informed by its manufacturer of an out-of-specification result from dissolution testing after 3 months of stability for lot KN6491. The cause was associated with a power failure that occurred during the coating process. The firm has also decided to withdraw lot KL2074 as a preventive measure.

Depth of distribution

Wholesalers and pharmacies in Canada.

Affected products

A. Pantoprazole

DIN, NPN, DIN-HIM
DIN 02385759
Dosage form

Tablets

Strength
  • 40 mg
Lot or serial number
  • KN6491
  • KL2074
Companies
Recalling Firm
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA
Marketing Authorization Holder
Sivem Pharmaceuticals ULC
4705 Dobrin Street
St. Laurent
H4R 2P7
Quebec
CANADA

Date modified: