The Recall Desk
ModerateFDA (Drugs)·D-1215-2018·Announced 2018-10-03

Baxter Recalls Levofloxacin Injection Bags Due to High Potency

Baxter Healthcare is recalling 523,896 bags of Levofloxacin Injection in 5% Dextrose because the drug 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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard involves a potency deviation (high concentration) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Baxter Healthcare Corporation is recalling 523,896 bags of Levofloxacin Injection in 5% Dextrose, 5 mg/mL. The affected products are packaged in 50 mL, 100 mL, and 150 mL container bags and are prescription-only. The recall was initiated because the levofloxacin concentration in the solution was found to be higher than the specified limits.

The recalled products were distributed nationwide in the United States and Puerto Rico. The specific lot numbers and expiration dates are detailed in the agency's recall notice. Baxter Healthcare is the recalling firm, and the products were manufactured for Claris Lifesciences Inc. by Claris Injectables Ltd. in Gujarat, India.

Healthcare providers and patients should stop using the affected lots of Levofloxacin Injection and contact their healthcare provider or Baxter Healthcare for further instructions. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The recalled product

Product
LEVOFLOXACIN (LEVOFLOXACIN)
Brand
LEVOFLOXACIN
Manufacturer
Baxter Healthcare Corporation
Category
Drug — Antibiotic
Hazard
Affected units
523,896

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 #: 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

UPCs (3)

  • 0336000047241
  • 0336000045018
  • 0336000046244

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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