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Health product recall

AmBisome

Starting date:
June 19, 2013
Posting date:
July 2, 2013
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-34377

Recalled products

  1. AmBisome

Reason

Two lots of AmBisome (042269AA and 0422C1AA) may have been exposed to bacterial contaminant during the manufacturing process.

Depth of distribution

Wholesalers and hospitals in all provinces in Canada.

Affected products

A. AmBisome

DIN, NPN, DIN-HIM
DIN 02241630
Dosage form
  • Lyophilized powder
Strength

50mg per vial (4 mg amphotericin B/mL when constituted)

Lot or serial number
  • 042269AA
  • 0422C1AA
Companies
Recalling Firm
Astellas Pharma Canada, Inc.
675 Cochrane Drive Suite 500 West Tower
Markham
L3R 0B8
Ontario
CANADA
Marketing Authorization Holder
Astellas Pharma Canada, Inc.
675 Cochrane Drive Suite 500 West Tower
Markham
L3R 0B8
Ontario
CANADA

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