Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24.
Check against the official notice below — it lists the full affected range.
Baxter Healthcare Corporation is recalling Levofloxacin Injection in 5% Dextrose, 750 mg strength, distributed nationwide in the USA and Puerto Rico. The recall affects 711,216 bags across multiple lot numbers with expiration dates ranging from July 2018 to October 2019. The reason for the recall is that these bags contain higher-than-specified concentrations of levofloxacin, meaning patients may receive a stronger dose of the antibiotic than intended.
The recall was issued because testing found the levofloxacin concentration in the solution exceeded acceptable limits. The affected lot numbers are identified in the recall notice, and consumers should check their medication against this list. The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Reason for recall: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. Distribution: Nationwide USA and Puerto Rico Quantity: 711,216 bags Lot/code info: Lot #: A060940, A060948, A060951, A060956, A060958, A060963, Exp 07/18; A061105, A061110, A061113, A061115, A061119, Exp 08/18; A061243, Exp 09/18; A0A0813, Exp 07/19; A0A0899, A0A0904, A0A0907, A0A0914, A0A0916, A0A0921, A0A0925, Exp 08/19; A0A0971, A0A0976, Exp 09/19; A0A0994, A0A0996, A0A0997, A0A0999, A0A1000, A0A1001, A0A1003, A0A1004, Exp 10/19.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.