CLASS III Drug recall · Reported 3 Oct 2018 · FDA Enforcement Report

Levofloxacin Injection in 5% Dextrose, 5 mg/mL recalled

Baxter Healthcare is recalling Levofloxacin Injection in 5% Dextrose, 5 mg/mL, distributed nationwide in the US. The recall was initiated on 25 Sep 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: 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

NDC36000-045, 36000-046, 36000-047, 36000-048

UPC0336000047241, 0336000045018, 0336000046244

Quantity recalled523,896 bags

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1215-2018
FDA event ID: 80987
Recalling firm: Baxter Healthcare, Deerfield, IL
Brand: Levofloxacin
Manufacturer: Baxter Healthcare Corporation
Classification: Class III
Status: Terminated
Recall initiated: 25 Sep 2018
FDA classified: 27 Sep 2018
Reported: 3 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Antibiotics

Timeline

25 Sep 2018	Recall initiated by company
27 Sep 2018	Classified by FDA	+2 days
3 Oct 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

Nationwide USA and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide USA and Puerto Rico

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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