Baxter Healthcare Corporation recalls Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag,
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Recall notice
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Contact the company & request your remedy
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We break every recall down into plain English — this one’s still on our list. Until our write-up is ready, the official FDA hazard and remedy below have the full, accurate details.
Source Page by GovInfoNow · govinfonow.com/recall/39831-baxter-healthcare-corporation-recalls-levofloxacin-injection-in-5-dextrose-250 · Recall date August 1, 2018 · FDA enforcement record: FDA #D-1034-2018
Cite this page
“Baxter Healthcare Corporation recalls Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag,.” GovInfoNow, recall dated August 1, 2018. https://govinfonow.com/recall/39831-baxter-healthcare-corporation-recalls-levofloxacin-injection-in-5-dextrose-250. Based on FDA recall #D-1034-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1034-2018%22&limit=1).
How to tell if you have this one
- Brand
Baxter Healthcare Corporation- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide USA and Puerto Rico- NDC
36000-045-01, 36000-046-24, 36000-047-24, 36000-048-24
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1034-2018 | 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.; Lot #: A061178, A061183, A061236, Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19 | 191,256 bags |
| D-1035-2018 | 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.; Lot#: A0A0954, A0A0958, A0A0970, Exp 09/19 | 106,320 bags |
| D-1036-2018 | 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.; 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. | 711,216 bags |
Contact Baxter Healthcare Corporation
We’ve drafted a message you can send Baxter Healthcare Corporation to request your refund or repair — edit it as you like.
Subject: Recall D-1034-2018 — Baxter Healthcare Corporation Baxter Healthcare Corporation recalls Levofloxacin Injection in 5% De Hello, I own a Baxter Healthcare Corporation recalls Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, that is covered by recall D-1034-2018 from Baxter Healthcare Corporation. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1034-2018 (August 1, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1034-2018 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.