FDAClass IIIAugust 15, 2018

Levofloxacin Injection in 5% Dextrose recall: Superpotent

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…

Why was Levofloxacin Injection in 5% Dextrose recalled?

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: A0A0954, A0A0958, A0A0970, Exp 09/19

Product
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…
Recalling firm
Baxter Healthcare Corporation
Quantity
106,320 bags
Distribution
Nationwide USA and Puerto Rico
Recall date
August 15, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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