D-0337-2018 Class I Terminated
FDA drug recall D-0337-2018 was initiated by AuroMedics Pharma LLC on December 20, 2017 and is designated Class I. Reason for recall: Presence of Particulate Matter; white particulate matter identified as mold was found in one bag The recall status is terminated (terminated June 24, 2019). Affected quantity: 9,050 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- February 14, 2018
- Initiation Date
- December 20, 2017
- Termination Date
- June 24, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,050 bags
Product Description
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
Distribution Pattern
Product was distributed throughout United States.
Code Information
Lot # CLZ160007, Exp August 2018