FDAFDA · Food and drugs·Recall number 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 only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51
Published February 14, 2018 · Recall initiated: December 20, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LINEZOLID
- Manufacturer
- AuroMedics Pharma LLC
- Distributor
- Product was distributed throughout United States.
- Lot
- Lot # CLZ160007, Exp August 2018
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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