Linezolid Injection 600 mg/300 mL — Class I drug recall D-0337-2018
Terminated recall by AuroMedics Pharma LLC, reported 2018-02-14. Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
| Recall number | D-0337-2018 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AuroMedics Pharma LLC, East Windsor, NJ, United States |
| Recall initiated | 2017-12-20 |
| Classified | 2018-02-08 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2019-06-24 |
| Quantity | 9,050 bags |
| Reason classes | microbial contamination, specification failure |
| Pathogens | mold |
| NDC | 55150-0242, 55150-0242-51 |
| Lot numbers | CLZ160007 |
| Expiration dates | 2018-08-20 |
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 for recall
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0337-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.