Superpotent Antibiotic Pulled

Baxter Healthcare Corporation is pulling more than 1 million bags of levofloxacin injection due to drug superpotency. The recall was announced in the August 15, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes the following products, which were manufactured for Claris Lifesciences by Claris Injectables:

• levofloxacin injection in 5% dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% dextrose, 50-mL single-use container bag (NDC 36000-046-24), from lots A061178, A061183, and A061236 (Exp. 9/18), A0A0937 (Exp. 8/19), and A0A1044 and A0A1048 (Exp. 10/19);
• levofloxacin injection in 5% dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% dextrose, 100-mL single-use container bag (NDC 36000-047-24), from lots A0A0954, A0A0958, and A0A0970 (Exp. 9/19); and
• levofloxacin injection in 5% dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% dextrose, 150-mL single-use container bag (NDC 36000-048-24), from lots A060940, A060948, A060951, A060956, A060958, and A060963 (Exp. 7/18), A061105, A061110, A061113, A061115, and A061119 (Exp. 8/18), A061243 (Exp. 9/18), A0A0813 (Exp. 7/19), A0A0899, A0A0904, A0A0907, A0A0914, A0A0916, A0A0921, and A0A0925 (Exp. 8/19); A0A0971 and A0A0976 (Exp. 9/19); and A0A0994, A0A0996, A0A0997, A0A0999, A0A1000, A0A1001, A0A1003, and A0A1004 (Exp. 10/19).

The affected bags were distributed throughout the United States and in Puerto Rico.

Baxter Healthcare Corporation voluntarily initiated the recall August 1, 2018, which was designated Class III by the FDA August 3, 2018. A class III designation suggests use of the drug is not likely to cause an adverse health reaction.

Levofloxacin injection is a prescription quinolone antibiotic used to treat various bacterial infections.

—Jolynn Tumolo

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