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Health product recall

Pantoprazole Sodium for Injection

Starting date:
October 29, 2010
Posting date:
November 22, 2010
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety, Quality
Audience:
Healthcare Professionals
Identification number:
RA-2010A243

Recalled products

  1. Pantoprazole Sodium for Injection

Reason

The recall decision was taken as a precautionary measure after an internal investigation identified a potential sterility assurance issue concerning the lots in question only.

Depth of distribution

Wholesalers and hospitals in Canada.

Affected products

Pantoprazole Sodium for Injection

DIN, NPN, DIN-HIM
DIN 02306727
Dosage form
  • Powder for solution
Strength
  • Pantoprazole Sodium 40 mg
Lot or serial number

4 Lots:

  • AR3580
  • AV8653
  • AV8656
  • AV8658
Companies
Recalling Firm
Sandoz Canada Inc. (Importer and Distributor) 145 Jules-Léger, Boucherville, Quebec J4B 7K8
Marketing Authorization Holder
Sandoz Canada Inc. (Importer and Distributor) 145 Jules-Léger, Boucherville, Quebec J4B 7K8
Recalling Firm
Sandoz Canada Inc. (Importer and Distributor)
145 Jules-Léger,
Boucherville
J4B 7K8
Quebec
CANADA
Marketing Authorization Holder
Sandoz Canada Inc. (Importer and Distributor)
145 Jules-Léger,
Boucherville
J4B 7K8
Quebec
CANADA