Class I
Terminated
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
- Company
- Auromedics Pharma Llc
- Recall Initiated
- December 20, 2017
- Posted
- February 14, 2018
- Recall Number
- D-0337-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9,050 bags
- Firm Location
- East Windsor, NJ, United States
Reason for Recall
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Distribution
Product was distributed throughout United States.
Lot / Code Info
Lot # CLZ160007, Exp August 2018
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