Class I · High risk Terminated
Linezolid Injection 600 mg/300 mL
Reason Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Linezolid Injection 600 mg per 300 mL
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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
What was recalled
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
- Recalling firm
- AuroMedics Pharma LLC
- NDC code
- 55150-242-51
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0703-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Linezolid recalls
See all
Class II · Moderate risk Terminated
Linezolid Injection 600 mg/300 mL Rx Only
Reason CGMP Deviations
Class II · Moderate risk Terminated
Linezolid Injection
Reason Lack of Assurance of Sterility: Due to potential for leaking bags.
Class II · Moderate risk Terminated
Linezolid various strengths in dextrose
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Linezolid active pharmaceutical ingredient packaged in varying…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
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