Ceftazidime injection recalled
WASHINGTON, D.C. — B. Braun Medical Inc. announced, with the cooperation of the U.S. Food and Drug Administration (FDA), that it instituted a nationwide recall for one (1) lot of the company’s Ceftazidime for Injection USP (2g) and its Dextrose Injection USP (50 mL) is a duplex container. According to B. Braun Medical, Inc.’s news release published by the FDA, the company issued the recall program because high molecular weight polymers results were out of specification. B. Braun Medical, Inc. has not received reports of adverse reactions to the impurity in its recalled medication. Notwithstanding, the drug maker said that it would announce the recall out of an abundance of caution.
Braun Medical, Inc. tested its duplex injection for Ceftazidime and found that the test results for one batch exceeded specification limitations for the high molecular weight polymers, or HWMP, at the 82-week interval. Consumption of out-of-specification HMWP is a possible safety hazard. Research shows that the consumption of HWMP caused kidney and liver damage in animal subjects. Notwithstanding, researchers are unsure about the effect HMWP will have on humans. The FDA requires drug manufacturers to use only stable HWMP in medications because of the possibility of consumption by a human could lead to illness or injury.
Ceftazidime for Injection and Dextrose Injection are anti-bacterial medications. Doctors administer these two injections for lower respiratory tract infections, bacterial septicemia, bone and joint infections, skin infections, intra-abdominal infections, gynecologic infections, and infections attacking the central nervous system.
The recalled injections are in a “flexible dual chamber” that combines the two medications. The recalled lot expiry is July 31, 2020. B. Braun Medical, Inc. said that it distributed the recalled injections nationwide.
Braun Medical, Inc. requests information from doctors about adverse reactions to the recalled injections. Additionally, the company recommends that physicians report all adverse reactions to the MedWatch program administered by the FDA.
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