FDA Recall D-0574-2018
AuroMedics Pharma LLC · East Windsor, NJ
Class I — life-threatening Terminated 810 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46
Reason for recall
Presence of Particulate Matter; contains visible particulate matter identified as mold.
Recall record
- Recall number
D-0574-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2018-01-12
- Classified by FDA Center
- 2018-03-01
- FDA published
- 2018-03-07
- Terminated
- 2020-04-01
- Recalling firm
- AuroMedics Pharma LLC
- Firm location
- East Windsor, NJ
Drug identification
- Brand name(s)
- LEVOFLOXACIN
- Generic name(s)
- LEVOFLOXACIN IN 5% DEXTROSE
- Manufacturer(s)
- Eugia US LLC
- NDC(s)
55150-243, 55150-244, 55150-245- Route(s)
- INTRAVENOUS