IntegraDose Compounding Services is recalling nine lots of the antibiotic cefazolin 2 gram in 20 mL syringe for injection and two lots of cefazolin 3 gram in 100 mL 0.9% sodium chloride bag for injection due to a lack of sterility assurance.
Intravenous administration of a non-sterile drug could result in serious infections ranging from fever, chills, and malaise, to severe adverse events such as septicemia, bacterial meningitides and wound infection which may be life-threatening. The possibility of a breach in sterility assurance in distributed product, while not confirmed, cannot be eliminated. No batches of product have been identified as containing microorganisms.
To date, IntegraDose Compounding Services has not received reports of any adverse events associated with this issue for these lots.
IntegraDose Compounding Services has notified its direct customers via a recall letter and is arranging for impacted product to be returned. Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine immediately. Consumers with questions regarding this recall can contact IntegraDose Compounding Services. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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