D-0574-2018 Class I Terminated
FDA drug recall D-0574-2018 was initiated by AuroMedics Pharma LLC on Jan 12, 2018 and is designated Class I. Reason for recall: Presence of Particulate Matter; contains visible particulate matter identified as mold. The recall status is terminated (terminated Apr 1, 2020). Affected quantity: 6,072 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 7, 2018
- Initiation Date
- Jan 12, 2018
- Termination Date
- Apr 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,072 bags
Product Description
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.
Distribution Pattern
Nationwide
Code Information
Lot CLF160003, exp May 2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0574-2018
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026