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.
What this means for you
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
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
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