AuroMedics Pharma LLC: Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA P

Is my product affected?

Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-245-52

• Brand LEVOFLOXACIN

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

What happened

AuroMedics Pharma LLC is recalling Levofloxacin in 5% Dextrose Injection (750 mg/150 mL bags for intravenous infusion) distributed nationwide in the United States. The recall affects 308,112 bags across multiple lots manufactured by Aurobindo Pharma Limited, with expiration dates ranging from July 2018 through September 2019. The recall was initiated due to lack of assurance of sterility, following a confirmed customer report of leaking bags and mold discovered between the outer bag and the overwrap.

The source document 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: 308112 bags Lot/code info: Lot/Batch #'s: CLF160012, CLF160014 exp July 2018; CLF170007, CLF170008, CLF170009, CLF170010, CLF170011, CLF170012, CLF170013 exp February 2019; CLF170014, CLF170015, CLF170016 exp March 2019; CLF170017, CLF170018, CLF170019, exp April 2019; CLF170020, CLF170021, CLF170022 exp May 2019; CLF170035, CLF170036, CLF170037, CLF170038 exp August 2019; CLF170048, CLF170049, CLF170050, CLF170051, CLF170052 exp September 2019

Source

Official record: FDA (Drug enforcement) ↗

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

Related recalls

• Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only, Manufactured By: Aurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-244-472018-03-27
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