Recalls / Class I
Class ID-0337-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Linezolid
- Generic name
- Linezolid
- Active ingredient
- Linezolid
- Route
- Intravenous
- NDC
- 55150-242
- FDA application
- ANDA206917
- Affected lot / code info
- Lot # CLZ160007, Exp August 2018
Why it was recalled
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Recalling firm
- Firm
- AuroMedics Pharma LLC
- Manufacturer
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, N/A, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 9,050 bags
- Distribution pattern
- Product was distributed throughout United States.
Timeline
- Recall initiated
- 2017-12-20
- FDA classified
- 2018-02-08
- Posted by FDA
- 2018-02-14
- Terminated
- 2019-06-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0337-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.