The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0615-2017·Announced 2017-04-05

Claris Lifesciences Recalls Levofloxacin Injection Due to Sterility Concerns

Claris Lifesciences Inc. is recalling Levofloxacin Injection due to a potential leak that may compromise sterility. The recall covers 24,456 units distributed nationwide.

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 with potential for significant injury (such as infection from a sterility breach in an IV product) are rated as Severe (4), as they are not Class I but involve risks beyond minor labeling errors.

Plain-English summary

Claris Lifesciences Inc. is recalling specific lots of Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL. The recall is due to a lack of assurance of sterility, as there is a potential for a leak from the primary container which may result in a breach of sterility and contamination of the product.

The affected product is Lot A060040, with an expiration date of December 2017. A total of 24,456 units (1,019 cartons containing 24 bags each) were distributed nationwide. The product is a prescription-only intravenous antibiotic manufactured for Claris Lifesciences Inc. in North Brunswick, NJ, by Claris Injectable Ltd. in Gujarat, India.

Patients and healthcare providers should stop using the affected product and contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
LEVOFLOXACIN (LEVOFLOXACIN)
Brand
LEVOFLOXACIN
Manufacturer
Claris Lifesciences Inc
Category
Drug — Antibiotic
Hazard

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 (2)

  • Lot #: A060040
  • Exp. Dec 2017

UPCs (3)

  • 0336000047241
  • 0336000045018
  • 0336000046244

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Claris Lifesciences 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 4 products in this recall →

Related recalls

Same brand · LEVOFLOXACIN

Same manufacturer · Claris Lifesciences Inc

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Same hazard · sterility breach

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