AuroMedics Pharma LLC: 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

Is my product affected?

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 LINEZOLID

Check against the official notice below — it lists the full affected range.

What happened

AuroMedics Pharma LLC is recalling Linezolid Injection 600 mg per 300 mL (2 mg/mL) distributed nationwide in the United States because the product lacks assurance of sterility. A customer reported leaking bags with mold found between the outer bag and the overwrap. The recall affects 395,150 bags across multiple lot numbers with expiration dates ranging from July 2018 through October 2019.

The affected lot numbers are: CLZ160001-CLZ160004 (exp. July 2018); CLZ160005, CLZ160006, CLZ160008-CLZ160010, CLZ160012 (exp. August 2018); CLZ160013-CLZ160016 (exp. October 2018); CLZ160017-CLZ160019, CLZ160021-CLZ160023 (exp. November 2018); CLZ170001-CLZ170006 (exp. March 2019); CLZ170007-CLZ170010 (exp. May 2019); CLZ170011-CLZ170012 (exp. June 2019); CLZ170013-CLZ170016 (exp. September 2019); and CLZ170017 (exp. October 2019). The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap

Details from the source

Reason for recall: Lack of Assurance of Sterility; confirmed customer report of a leaking bags and mold found between the outer bag and the overwrap Distribution: US Nationwide Quantity: 395150 bags 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

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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