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Vancomycin Hydrochloride for Injection USP
- Starting date:
- February 7, 2013
- Posting date:
- March 1, 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-23809
Recalled Products
A. Vancomycin Hydrochloride for Injection USP
Reason
The fabricator Fresenius Kabl USA has observed some cracked vials during their recent media fill testing which utilized the same batch of glass vials as that used to make this commercial product.
The manufacturer’s assessment is that a cracked vial could result in glass particulates appearing in the solution, in addition, a non-integral vial may be associated with the potential for microbial and/or fungal contamination.
Depth of distribution
Hospital Pharmacies
Affected products
A. Vancomycin Hydrochloride for Injection USP
DIN, NPN, DIN-HIM
DIN 02241807Dosage form
Powder for Solution (injectable)
Strength
10 g / vial
Lot or serial number
6105276
Companies
- Recalling Firm
-
Pharmaceutical Partners of Canada Inc.
Suite 200, 45 Vogell Road
Richmond Hill
L4B 3P6
Ontario
CANADA
- Marketing Authorization Holder
-
Pharmaceutical Partners of Canada Inc.
Suite 200, 45 Vogell Road
Richmond Hill
L4B 3P6
Ontario
CANADA