FDA Warns Against Use of Recalled Bupivacaine Injections from Huons Co., Ltd.

The U.S. Food and Drug Administration (FDA) has announced that Bupivacaine Hydrochloride in Dextrose Injection, USP, manufactured by Huons Co., Ltd., should be removed from certain convenience kits due to a manufacturer-initiated recall. Medline has issued a correction letter to affected customers, advising them to remove the included injections from their kits prior to continued use.

The recall follows a recent FDA inspection of Huons' manufacturing facility, which identified significant quality issues. Using compromised injectables poses risks such as infection, inflammatory response, and reduced anesthetic effectiveness. Specifically, neuraxial administration carries a risk of cerebral fluid contamination and meningitis, potentially progressing to encephalitis.

The FDA has identified this as the most serious type of recall, warning that continued use without correction may cause serious injury or death. As of April 10, Medline has reported no serious injuries or deaths associated with this issue. Customers with questions or concerns should contact Medline Industries.