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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
- 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