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The company voluntarily recalls Preservative-Free Bupivacaine HCl Injection, USP due to potential iron oxide particulates.
Hospira announced on April 23, 2015 it was voluntarily recalling one lot of Preservative-Free Bupivacaine hydrochloride (HCl) Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016). The recall comes after confirmed complaints from a customer of orange and black, visible particles found in a single-dose glass teartop vial. The recalled lot was distributed from July to September 2014.
Hospira has identified the particles as iron oxide and is investigating the root cause of the particulates. The company says it working with their glass supplier as part of the investigation.