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Health product recall

Cefoxitine for Injection (2015-04-24)

Starting date:
April 24, 2015
Posting date:
May 1, 2015
Type of communication:
Drug Recall
Subcategory:
Drugs
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-53223

Recalled Products

A. Cefoxitine for Injection 1 g/vial

B. Cefoxitine for Injection 10 g/vial

Reason

Possible presence of dark particles of Active Pharmaceutical Ingredient (API) in the vials, observed only after reconstitution.

Depth of distribution

Wholesalers, retailers and hospitals

Affected products

A. Cefoxitine for Injection 1 g/vial

DIN, NPN, DIN-HIM
DIN 02128187
Dosage form

Powder for Solution

Strength

Cefoxitin (Cefoxitin sodium) 1 g/vial

Lot or serial number

0001D4

Companies
Recalling Firm
Teva Canada Ltd.
30 Novopharm Court,
Toronto
M1B 2K9
Ontario
CANADA
Marketing Authorization Holder
Teva Canada Ltd.
30 Novopharm Court,
Toronto
M1B 2K9
Ontario
CANADA

B. Cefoxitine for Injection 10 g/vial

DIN, NPN, DIN-HIM
DIN 02240773
Dosage form

Powder for Solution

Strength

Cefoxitin (Cefoxitin sodium) 10 g/vial

Lot or serial number

0001D4

Companies
Recalling Firm
Teva Canada Ltd.
30 Novopharm Court,
Toronto
M1B 2K9
Ontario
CANADA
Marketing Authorization Holder
Teva Canada Ltd.
30 Novopharm Court,
Toronto
M1B 2K9
Ontario
CANADA

Date modified: