Levofloxacin Injection, Solution
FDA Recall NDC 36000-045
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 5 recorded enforcement report(s) associated with Levofloxacin (NDC 36000-045). A significant event, classified as Class III, was initiated on Sep 25, 2018 by Baxter Healthcare Corporation. The reported reason for this action was: "Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Sep 25, 2018
Oct 03, 2018
523,896 bags
Recall Profile & Regulatory Data
Event ID
80987
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Puerto Rico
Termination Date
Jun 26, 2020
Product Description
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.
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
36000-045-01Product
36000-046-24Product
36000-047-24Product
36000-048-24Product
Class III Terminated
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Aug 01, 2018
Aug 15, 2018
191,256 bags
Recall Profile & Regulatory Data
Event ID
80653
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Puerto Rico
Termination Date
Jul 16, 2020
Product Description
Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.
Batch or Lot Expiration Information
Lot# : A061178, A061183, A061236, Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19
Affected Packages Involved in this Recall
36000-045-01Product
36000-046-24Product
36000-047-24Product
36000-048-24Product
Class III Terminated
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Aug 01, 2018
Aug 15, 2018
711,216 bags
Recall Profile & Regulatory Data
Event ID
80653
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Puerto Rico
Termination Date
Jul 16, 2020
Product Description
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.
Batch or Lot Expiration Information
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.
Affected Packages Involved in this Recall
36000-045-01Product
36000-046-24Product
36000-047-24Product
36000-048-24Product
Class III Terminated
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Aug 01, 2018
Aug 15, 2018
106,320 bags
Recall Profile & Regulatory Data
Event ID
80653
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA and Puerto Rico
Termination Date
Jul 16, 2020
Product Description
Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24.
Batch or Lot Expiration Information
Lot# : A0A0954, A0A0958, A0A0970, Exp 09/19
Affected Packages Involved in this Recall
36000-045-01Product
36000-046-24Product
36000-047-24Product
36000-048-24Product
Class II Terminated
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Mar 10, 2017
Apr 05, 2017
24,456 units (1019 cartons x 24 bags)
Recall Profile & Regulatory Data
Event ID
76733
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Claris Lifesciences Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 18, 2020
Product Description
Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24
Batch or Lot Expiration Information
Lot# : A060040, Exp. Dec 2017
Affected Packages Involved in this Recall
36000-045-01Product
36000-046-24Product
36000-047-24Product
36000-048-24Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
