The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0708-2018·Announced 2018-05-09

AuroMedics Recalls Levofloxacin Injection Bags Due to Sterility Concerns

AuroMedics Pharma LLC is recalling specific lots of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and reports of leaking bags with mold.

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 and involves a lack of assurance of sterility with confirmed reports of mold and leaking bags, which poses a significant risk of serious injury or infection.

Plain-English summary

AuroMedics Pharma LLC is recalling 308,472 bags of Levofloxacin in 5% Dextrose Injection, 500 mg (5 mg/mL) in 100 mL, for intravenous infusion. The recall is being conducted because of a lack of assurance of sterility. The company received a confirmed customer report of leaking bags and mold found between the outer bag and the overwrap.

The affected product is manufactured by Aurobindo Pharma Limited in India for AuroMedics Pharma, LLC. The recall covers specific lot numbers with expiration dates ranging from June 2018 to August 2019. The product was distributed nationwide in the United States.

Healthcare providers and patients should stop using the affected lots immediately. Patients who have received the medication should contact their healthcare provider for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE)
Brand
LEVOFLOXACIN
Manufacturer
AuroMedics Pharma LLC
Category
Drug — Antibiotic Injection
Hazard
Affected units
308,472

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/Batch #'s: CLF160008
  • CLF160009
  • CLF160010
  • CLF160011
  • exp June 2018
  • CLF160015
  • CLF160016
  • CLF160017
  • exp August 2018
  • CLF170001 exp December 2018
  • CLF170023
  • CLF170024
  • exp May 2019
  • CLF170039
  • CLF170040
  • CLF170041
  • CLF170042
  • CLF170043
  • CLF170044
  • CLF170045

UPCs (1)

  • 0355150244478

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by AuroMedics Pharma LLC 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 7 products in this recall →

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