Teva Canada Limited in consultation with Health Canada has initiated a voluntary recall of one lot each of Cefoxitin (1g/vial; lot number 0001D4 and 10g/vial; lot number 0001D4) Injection due to the presence of dark Active Pharmaceutical Ingredient (API) particles in the vials, observed by visual inspection only upon reconstitution. The presence of particles in vials of the affected lot could pose the following risks, if injected: local inflammation, phlebitis, allergic response, infection and/or embolization in the body. The number of particles observed is very low, therefore the likelihood of a health hazard occurring in a patient who is administered this product is low. This recall does not affect any other lots of Cefoxitin for Injection supplied by Teva Canada Limited. As a precautionary measure, all parenteral drug products should be inspected visually for the presence of particulate matter. Every container whose contents show evidence of visible particulates should not be used and should be reported to Teva Canada Limited.
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