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Class I Recall Issued for Intravenous Antibiotic

May 08, 2020

B. Braun Medical Inc. is recalling 22,488 Duplex containers of intravenous ceftazidime and dextrose, citing failed stability specifications indicating high molecular weight polymers, according to the May 6, 2020, US Food and Drug Administration (FDA) Enforcement Report. The FDA designated the recall Class I, warning that use of the affected product could cause serious adverse health consequences or death. 

The recall affects 50-mL containers of ceftazidime and dextrose, 2 g (NDC 0264-3145-11), from lot H8J812 (Exp. 7/31/20). The product was distributed throughout the United States. 

B. Braun Medical initiated the recall April 18, 2020. On April 28, 2020, the FDA issued the Class I designation.  

Ceftazidime is a prescription cephalosporin antibiotic used to treat a wide variety of bacterial infections.

Jolynn Tumolo

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