Drug 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
D-0337-2018
Product summary
- Event
- Event 78800
- Status
- Terminated
- Classification
- Class I
- Quantity
- 9,050 bags
- Official record key
drug-enforcement:D-0337-2018
Official wording
Reason: Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Code information: Lot # CLZ160007, Exp August 2018
Distribution pattern: Product was distributed throughout United States.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter
-
Microbial contamination
mold was found