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
Reported: February 14, 2018 Initiated: December 20, 2017 #D-0337-2018
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
Details
- Recalling Firm
- AuroMedics Pharma LLC
- Units Affected
- 9,050 bags
- Distribution
- Product was distributed throughout United States.
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by AuroMedics Pharma LLC. Units affected: 9,050 bags.
Why was this product recalled? ▼
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 14, 2018. Severity: Critical. Recall number: D-0337-2018.
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