Medicine recalls
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| The United States: B. Braun Medical Inc. issues voluntary nationwide recall of one lot of Ceftazidime for Injection USP and Dextrose Injection USP, Duplex Container due to out-of-specification results for High Molecular Weight Polymers |
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The US Food and Drug Administration (FDA) announces that B. Braun Medical Inc. is voluntarily recalling one lot of Ceftazidime for Injection USP (2g) and Dextrose Injection USP (50 ml) in Duplex® Container (lot number: H8J812) to the hospital/user level. During stability testing of Batch H8J812, test results were found to exceed the specification limits for High Molecular Weight Polymers (HMWP) at the nineteen (19) month [82 week] stability interval.
Elevated levels of HMWP have been shown to cause kidney damage and liver issues in animal studies. While the impact of HMWP in humans is unknown, B. Braun is initiating this voluntary recall out of an abundance of caution to prevent any risks of adverse reactions due to the elevated HMWP levels. To date there have been no complaints or reports of adverse reactions associated with this product lot.
Ceftazidime for Injection USP and Dextrose Injection USP in Duplex® Container is a flexible dual chamber container containing approximately 50 ml of 5% Dextrose Injection in the diluent chamber and ceftazidime in the drug powder chamber. After reconstitution, the concentration is equivalent to 2 g ceftazidime.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/b-braun-medical-inc-issues-voluntary-nationwide-recall-one-1-lot-ceftazidime-injection-usp-and
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Apr 21, 2020
Issued at HKT 15:00
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