The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0494-2021·Announced 2021-06-02

Cardinal Health Recalls Levofloxacin Injection Due to Temperature Excursions

Cardinal Health Inc. is recalling 35 bags of Levofloxacin Injection due to intermittent temperature excursions during storage.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), as they may cause temporary or medically reversible adverse health consequences.

Plain-English summary

Cardinal Health Inc. is recalling 35 bags of Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers. The product is identified by NDC 0143-9721-24 and code 2007046.1. The recall was initiated because of intermittent exposure to temperature excursions during storage, which constitutes a Current Good Manufacturing Practice (CGMP) deviation.

The affected product was distributed to facilities in Florida, Georgia, and South Carolina. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and facilities in the affected states should check their inventory for the specific NDC and code listed above. If the product is found, it should be quarantined and not administered to patients. Consumers should contact their healthcare provider if they have received this specific medication.

The recalled product

Product
LEVOFLOXACIN (LEVOFLOXACIN)
Brand
LEVOFLOXACIN
Manufacturer
Cardinal Health Inc.
Category
Drug — Antibiotic Injection
Hazard
Affected units
35

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 (1)

  • 2007046.1

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. 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 198 products in this recall →

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