Baxter Healthcare Corporation: Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx on

Is my product affected?

Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.

• Brand LEVOFLOXACIN

Check against the official notice below — it lists the full affected range.

What happened

Baxter Healthcare Corporation is recalling Levofloxacin Injection in 5% Dextrose at a concentration of 5 mg/mL across three package sizes: 50 mL, 100 mL, and 150 mL container bags. The recall affects approximately 523,896 bags distributed nationwide in the USA and Puerto Rico. The reason for the recall is that the recalled lots contain higher-than-specified concentrations of levofloxacin, making the drug superpotent.

The affected lots have various expiration dates ranging from February 2019 through October 2019. Specific lot numbers are identified for each package size, with lot numbers beginning with "A061" or "A0A" followed by additional digits. The recall source does not specify a remedy or recommended action for consumers who may have received affected units.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

Details from the source

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: 523,896 bags Lot/code info: Lot #: a) A061178, A061183, A061236, Exp. Date 09/2018; A0A0937, Exp. Date 08/2019; A0A1044, A0A1048, Exp. Date 10/2019. b) A0A0741, A0A0747, A0A0748, Exp. Date 6/2019; A0A0814, A0A0815, A0A0823, Exp.Date 7/2019; A0A0889, A0A0893, Exp. Date 8/2019; A0A0954, A0A0958, A0A0970, Exp. Date 09/2019; A0A1005, A0A1006, A0A1008, A0A1012, A0A1016, A0A1028, A0A1036, Exp. 10/2019. c) A061243, Exp. Date 09/2018; A0A0258, Exp. Date 2/2019; A0A0813, Exp. Date 07/2019; A0A0899, A0A0904, A0A0907, A0A0914, A0A0916, A0A0921, A0A0925, Exp. Date 08/2019; A0A0971, A0A0976, Exp. Date 09/2019; A0A0994, A0A0996, A0A0997, A0A0999, A0A1000, A0A1001, A0A1003, A0A1004, Exp. Date 10/2019

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• 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 36000-048-24.2018-08-01
• Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-244-472018-03-27
• Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-522018-03-27
• Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-612022-04-13
• Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-0106-012018-09-19

All FDA (Drug enforcement) recalls