NDC 36000-048
Levofloxacin 5 mg per 1 mL injection, solution
On the label: Baxter Healthcare Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Pharmaceuticals India Private Limited | Ahmedabad, India | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionJan 27, 2023 · 9 inspections, 3 with FDA action |
Recalls
- Sep 25, 2018 · Class III · Baxter Healthcare Corporation
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Lots: 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; A0A… - Aug 1, 2018 · Class III · Baxter Healthcare Corporation
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Lots: Lot #: A061178, A061183, A061236, Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19 - Aug 1, 2018 · Class III · Baxter Healthcare Corporation
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Lots: Lot#: A0A0954, A0A0958, A0A0970, Exp 09/19 - Aug 1, 2018 · Class III · Baxter Healthcare Corporation
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Lots: 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, A… - Mar 10, 2017 · Class II · Claris Lifesciences Inc
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.
Lots: Lot #: A060040, Exp. Dec 2017
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Levofloxacin: every company that makes it
- Form
- injection, solution
- Strength
- 5 mg per 1 mL
- Approval
- ANDA ANDA091397
- On the market since
- Jul 1, 2013
- Package NDCs
36000-048-24- Official label
- DailyMed (National Library of Medicine), updated Mar 22, 2019
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