FDA Drug recall D-0337-2018
Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx…
- FDA Drug
- Class I
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class I recall of Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx… by Auromedics Pharma, citing presence of Particulate Matter; white particulate matter identified as mold was found in one bag.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0337-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-12-20 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Auromedics Pharma |
| Distribution | n/a |
Product
Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51
Reason
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Identifiers
| ndc | 55150-242-51 |
|---|---|
| code_info | Lot # CLZ160007, Exp August 2018 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0337-2018%22
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