Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Subpotent product:out of specification assay results observed during long term stability testing.
Reason Subpotent product:out of specification assay results observed during long term stability testing.
Reason Subpotent product:out of specification assay results observed during long term stability testing.
Reason Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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