AuroMedics Recalls Levofloxacin Injection Bags Due to Mold Contamination
AuroMedics Pharma LLC is recalling 6,072 bags of Levofloxacin in 5% Dextrose Injection because they contain visible particulate matter identified as mold.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classifies this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
AuroMedics Pharma LLC is recalling 6,072 bags of Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container. The recall is being conducted because the product contains visible particulate matter that has been identified as mold.
The affected product is identified by Lot CLF160003 with an expiration date of May 2018. The product is distributed nationwide. The drug is a prescription-only intravenous antibiotic manufactured for AuroMedics Pharma LLC.
Consumers and healthcare providers should stop using the affected product immediately and contact their healthcare provider or pharmacist for further instructions. The FDA classifies this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE)
- Brand
- LEVOFLOXACIN
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Antibiotic
- Affected units
- 6,072
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 CLF160003
- exp May 2018
UPCs (1)
- 0355150244478
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · LEVOFLOXACIN
- HighLevofloxacin 500 mg Tablets Recalled Due to Manufacturing Temperature Abuse
FDA (Drugs) · 2022-06-15
- SevereCardinal Health Recalls Levofloxacin Injection Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateBaxter Recalls Levofloxacin Injection Bags Due to High Potency
FDA (Drugs) · 2018-10-03
- ModerateBaxter Recalls Levofloxacin Injection Due to High Potency Levels
FDA (Drugs) · 2018-08-15
- LowBaxter Recalls Levofloxacin Injection Due to High Potency Levels
FDA (Drugs) · 2018-08-15
Same manufacturer · AuroMedics Pharma LLC
See all →- HighFondaparinux Sodium Injection Recalled Nationwide for Subpotent Formulation
FDA (Drugs) · 2022-11-02
- HighAcyclovir Sodium Injectable Recalled for Particulate Matter
FDA (Drugs) · 2022-10-26
- LowTranexamic Acid Injection Recalled for Metal Particulate Matter
FDA (Drugs) · 2022-10-12
- SeverePolymyxin B for Injection Recalled Due to Particulate Matter Contamination
FDA (Drugs) · 2022-02-16
- SevereAuroMedics Recalls Acetaminophen Injection Due to Discoloration and pH Failures
FDA (Drugs) · 2021-02-10
Same hazard · mold contamination
See all →- CriticalAVID Medical Recalls Halyard IV Start Kits Due to Mold Contamination
FDA (Devices) · 2026-09-30
- SevereAVID Medical Recalls Halyard IV Start Kits Due to Mold Contamination
FDA (Devices) · 2026-09-23
- HighTurmeric capsules recalled over mold contamination in raw material lots
FDA (Food) · 2026-02-04
- ModeratePariva Marinated Labneh Bites Recalled for Potential Mold Contamination
FDA (Food) · 2024-08-21
- HighPariva Marinated Labneh Bites Recalled Due to Potential Mold Contamination
FDA (Food) · 2024-08-21
Similar recalls
- SevereAuroMedics Recalls Levofloxacin Injection Bags Due to Sterility Concerns
FDA (Drugs) · 2018-05-09
- SevereAuroMedics Recalls Levofloxacin IV Bags Due to Sterility Concerns
FDA (Drugs) · 2018-05-09
- CriticalAuroMedics Recalls Linezolid Injection Bags Due to Mold Contamination
FDA (Drugs) · 2018-02-14
- SevereAuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns
FDA (Drugs) · 2018-05-09
- SevereAuroMedics Recalls Linezolid Injection Bags Due to Sterility Concerns
FDA (Drugs) · 2018-05-09
- ModerateBaxter Recalls Levofloxacin Injection Due to High Potency Levels
FDA (Drugs) · 2018-08-15