D-1215-2018 Class III Terminated
FDA drug recall D-1215-2018 was initiated by Baxter Healthcare Corporation on Sep 25, 2018 and is designated Class III. Reason for recall: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution. The recall status is terminated (terminated Jun 26, 2020). Affected quantity: 523,896 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 3, 2018
- Initiation Date
- Sep 25, 2018
- Termination Date
- Jun 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 523,896 bags
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.
Reason for Recall
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Distribution Pattern
Nationwide USA and Puerto Rico
Code 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1215-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026