Particulates in B. Braun Injectables Prompt Recall
B. Braun is recalling a lot of two injectable drugs after visible organic particulates, a potentially life-threatening safety hazard, were discovered in a single reserve sample unit.
The drugmaker announced the voluntary recall of one lot of cefepime injection, USP and dextrose injection, USP on Oct. 15. It hasn’t received any adverse events for the lot, which was distributed between February and March of this year.
B. Braun didn’t identify the particulates, but noted that visible particle matter such as metals, cotton fibers or hair could create inflammatory responses in patients and could become life-threatening for certain patients.
The product is used as a cephalosporin antibacterial indicated in the treatment of infections caused by susceptible strains of designated microorganisms. The product is packaged in a duplex single dose intravenous, plastic container with 24 units per case.
“B. Braun regularly reviews its production and process controls, and is focused on further enhancing its production ad process controls in order to minimize the potential for particulate generation and to detect particulate matter prior to batch release,” a company spokesperson said Oct. 17. “B. Braun is committed to working closely with the FDA, healthcare providers and other key stakeholders to address this recall.”
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