The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0709-2018·Announced 2018-05-09

AuroMedics Recalls Levofloxacin IV Bags Due to Sterility Concerns

AuroMedics Pharma LLC is recalling 308,112 bags of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and a confirmed report of 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 confirmed report of mold and lack of sterility assurance in an intravenous product, which poses a significant risk of serious injury or hospitalization.

Plain-English summary

AuroMedics Pharma LLC is recalling 308,112 bags of Levofloxacin in 5% Dextrose Injection, 750 mg (5 mg/mL) in 150 mL, for intravenous infusion. The recall was initiated due to a lack of assurance of sterility, following a confirmed customer report of leaking bags and mold found between the outer bag and the overwrap.

The affected product is distributed nationwide in the United States. The recall includes specific lot numbers with expiration dates ranging from July 2018 to September 2019. The product is a prescription-only medication manufactured by Aurobindo Pharma Limited in India for AuroMedics Pharma, LLC.

Healthcare providers and patients should stop using the affected lots immediately and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could 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
Hazard
Affected units
308,112

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: CLF160012
  • CLF160014 exp July 2018
  • CLF170007
  • CLF170008
  • CLF170009
  • CLF170010
  • CLF170011
  • CLF170012
  • CLF170013 exp February 2019
  • CLF170014
  • CLF170015
  • CLF170016 exp March 2019
  • CLF170017
  • CLF170018
  • CLF170019
  • exp April 2019
  • CLF170020
  • CLF170021
  • CLF170022 exp May 2019
  • CLF170035

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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