The Recall Desk
SevereFDA (Drugs)·D-0704-2018·Announced 2018-05-09

AuroMedics Recalls Levofloxacin IV 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 a confirmed report of leaking bags with mold.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text confirms a customer report of mold found between the outer bag and the overwrap of an intravenous drug, which constitutes a significant injury risk and aligns with the rubric criteria for Severe (score 4) involving significant injury reports or high-risk contamination.

Plain-English summary

AuroMedics Pharma LLC is recalling 46,824 bags of Levofloxacin in 5% Dextrose Injection, 250 mg (5 mg/mL) in 50 mL, for intravenous infusion. The product is distributed nationwide in the United States. The recall involves specific lots with expiration dates ranging from May 2018 to August 2019.

The recall was initiated due to a lack of assurance of sterility. A confirmed customer report indicated that bags were leaking and mold was found between the outer bag and the overwrap. The affected lots are CLF160002, CLF160004, CLF160005, CLF160006, CLF160007, CLF170027, and CLF170029.

Healthcare providers and patients should stop using the affected product and contact AuroMedics Pharma LLC 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 IN 5% DEXTROSE)
Brand
LEVOFLOXACIN
Manufacturer
AuroMedics Pharma LLC
Category
Drug — Antibiotic
Hazard
Affected units
46,824

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 (7)

  • Lot/Batch #'s: CLF160002
  • CLF160004
  • CLF160005 exp May 2018
  • CLF160006
  • CLF160007 exp June 2018
  • CLF170027 exp July 2019
  • CLF170029 exp August 2019

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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Same hazard · mold

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