Antibiotic Injection Pulled

Citing superpotency concerns, Baxter Healthcare Corporation has issued a voluntary recall for more than 500,000 bags of levofloxacin injection in 5% dextrose. According to the October 3, 2018, US Food and Drug Administration (FDA) Enforcement Report, samples of the injection tested above specification for levofloxacin concentration.

The recall affects two levofloxacin products manufactured for Claris Lifesciences Inc. by Claris Injectables Ltd. and distributed in the United States and Puerto Rico:

• levofloxacin injection in 5% dextrose, 500 mg (5 mg/mL), 100-mL container bags (NDC 36000-047-24) from lots A0A0741, A0A0747, and A0A0748 (Exp. 6/19), A0A0814, A0A0815, and A0A0823 (Exp. 7/19), A0A0889 and A0A0893 (Exp. 8/19), and A0A1005, A0A1006, A0A1008, A0A1012, A0A1016, A0A1028, and A0A1036 (Exp. 10/2019); and
• levofloxacin injection in 5% dextrose, 750 mg (5 mg/mL), 150-mL container bags (NDC 36000-048-24) from lot A0A0258 (Exp. 2/19).

Baxter Healthcare Corporation voluntarily initiated the recall September 25, 2018. Two days later, the FDA designated the recall Class III, suggesting use of the affected product is unlikely to cause adverse health consequences.

Levofloxacin is a prescription antibiotic injection used to treat a variety of bacterial infections.

—Jolynn Tumolo

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