The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1035-2018·Announced 2018-08-15

Baxter Recalls Levofloxacin Injection Due to High Potency Levels

Baxter Healthcare is recalling specific lots of Levofloxacin Injection in 5% Dextrose because the solution concentration was higher than specified.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The source text explicitly identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Baxter Healthcare Corporation is recalling 106,320 bags of Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 100 mL Single Use Container bags. The product is a prescription-only intravenous antibiotic manufactured for Claris Lifesciences Inc. and by Claris Injectables Ltd. The affected lots are A0A0954, A0A0958, and A0A0970, with an expiration date of 09/19.

The recall was initiated because the product had high out-of-specification results, resulting in an increased concentration of the solution. This is classified as a Class III recall by the FDA, indicating that the violation is not likely to cause adverse health consequences.

The affected product was distributed nationwide in the United States and Puerto Rico. Healthcare providers and patients should stop using the affected lots and contact their pharmacist or healthcare provider for guidance on replacement or disposal.

The recalled product

Product
LEVOFLOXACIN (LEVOFLOXACIN)
Brand
LEVOFLOXACIN
Manufacturer
Baxter Healthcare Corporation
Category
Drug — Antibiotic
Hazard
Affected units
106,320

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

UPCs (3)

  • 0336000047241
  • 0336000045018
  • 0336000046244

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Baxter Healthcare Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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