The Recall Desk
ModerateFDA (Drugs)·D-1036-2018·Announced 2018-08-15

Baxter Recalls Levofloxacin Injection Due to High Concentration Levels

Baxter Healthcare is recalling 711,216 bags of Levofloxacin Injection in 5% Dextrose because the solution concentration was higher than specified.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The specific defect is a concentration deviation rather than a contamination or labeling error involving a common allergen.

Plain-English summary

Baxter Healthcare Corporation is recalling 711,216 bags of Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 150 mL Single Use Container bags. The product is a prescription-only intravenous antibiotic manufactured for Claris Lifesciences Inc. and distributed nationwide in the USA and Puerto Rico.

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 an FDA Class III recall, which indicates that the product is not likely to cause adverse health consequences.

Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be quarantined and not administered. Patients who have already received the medication should contact their healthcare provider if they have concerns.

The recalled product

Product
LEVOFLOXACIN (LEVOFLOXACIN)
Brand
LEVOFLOXACIN
Manufacturer
Baxter Healthcare Corporation
Category
Drug — Antibiotic
Hazard
Affected units
711,216

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 (20)

  • 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

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 →

Related recalls

Same brand · LEVOFLOXACIN

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · concentration deviation

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