Linezolid Injection, Solution
FDA Recall NDC 55150-242
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Linezolid (NDC 55150-242). A significant event, classified as Class II, was initiated on Mar 27, 2018 by Eugia Us Llc. The reported reason for this action was: "Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
March 2018 Class II Recall: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Recall Number
Class II Terminated
Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap
Mar 27, 2018
May 09, 2018
395150 bags
Recall Profile & Regulatory Data
Event ID
79772
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide
Termination Date
Feb 18, 2022
Product Description
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
Batch or Lot Expiration Information
Lot# Lot/
Lot# '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
Affected Packages Involved in this Recall
55150-242-51Product
December 2017 Class I Recall: Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Recall Number
Class I Terminated
Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Dec 20, 2017
Feb 14, 2018
9,050 bags
Recall Profile & Regulatory Data
Event ID
78800
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Product was distributed throughout United States.
Termination Date
Jun 24, 2019
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
Batch or Lot Expiration Information
Lot# CLZ160007, Exp August 2018
Affected Packages Involved in this Recall
55150-242-51Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
