AuroMedics Pharma LLC: 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 P

Is my product affected?

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 55150-244-47

• 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 (500 mg Levofloxacin per 100 mL bag) distributed nationwide because of a lack of assurance of sterility. A customer reported leaking bags with mold found between the outer bag and the overwrap. The recall affects approximately 308,472 bags across multiple lot numbers with expiration dates ranging from June 2018 to August 2019.

The affected lot numbers are CLF160008, CLF160009, CLF160010, CLF160011 (expiring June 2018); CLF160015, CLF160016, CLF160017 (expiring August 2018); CLF170001 (expiring December 2018); CLF170023, CLF170024 (expiring May 2019); and CLF170039 through CLF170047 (expiring August 2019). The source document does not specify what action affected consumers should take in response to this recall.

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: 308472 bags Lot/code info: Lot/Batch #'s: CLF160008, CLF160009, CLF160010, CLF160011, exp June 2018; CLF160015, CLF160016 , CLF160017, exp August 2018; CLF170001 exp December 2018; CLF170023, CLF170024, exp May 2019; CLF170039, CLF170040, CLF170041, CLF170042, CLF170043, CLF170044, CLF170045, CLF170046, CLF170047 exp August 2019

Source

Official record: FDA (Drug enforcement) ↗

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

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