Recalls / Class II
Class IID-0703-2018
Product
Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, 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/Batch #'s: CLZ160001, CLZ160002, CLZ160003, CLZ160004 exp July 2018; CLZ160005, CLZ160006, CLZ160008, CLZ160009, CLZ160010 and CLZ160012, exp August 2018; CLZ160013, CLZ160014, CLZ160015, CLZ160016, exp October 2018; CLZ160017, CLZ160018, CLZ160019, CLZ160021, CLZ160022, CLZ160023, exp November 2018; CLZ170001, CLZ170002, CLZ170003, CLZ170004, CLZ170005, CLZ170006, exp March 2019; CLZ170007, CLZ170008, CLZ170009, CLZ170010, exp May 2019; CLZ170011, CLZ170012, exp June 2019; CLZ170013, CLZ170014, CLZ170015, CLZ170016, exp, September 2019; CLZ170017, exp October 2019
Why it was recalled
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
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
- 395150 bags
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2018-03-27
- FDA classified
- 2018-05-03
- Posted by FDA
- 2018-05-09
- Terminated
- 2022-02-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0703-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.