D-1035-2018 Class III Terminated
FDA drug recall D-1035-2018 was initiated by Baxter Healthcare Corporation on Aug 1, 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 Jul 16, 2020). Affected quantity: 106,320 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 15, 2018
- Initiation Date
- Aug 1, 2018
- Termination Date
- Jul 16, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 106,320 bags
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.
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#: A0A0954, A0A0958, A0A0970, Exp 09/19
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1035-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026