FDA Recall D-0337-2018
AuroMedics Pharma LLC · East Windsor, NJ
Class I — life-threatening Terminated 551 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-0337-2018- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed throughout United States.
- Recall initiated
- 2017-12-20
- Classified by FDA Center
- 2018-02-08
- FDA published
- 2018-02-14
- Terminated
- 2019-06-24
- Recalling firm
- AuroMedics Pharma LLC
- Firm location
- East Windsor, NJ
Drug identification
- Brand name(s)
- LINEZOLID
- Generic name(s)
- LINEZOLID
- Manufacturer(s)
- Eugia US LLC
- NDC(s)
55150-242- Route(s)
- INTRAVENOUS