Levofloxacin in 5% Dextrose Injection, 750 mg Levofloxacin (5 mg/mL) in 150 mL of 5% Dextrose, For Intravenous…

Is this the product you have?

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

Lot codes and dates

7 of 7 products

Products covered by this recall

#	Product as published
1	CLF160012, CLF160014 exp July 2018
2	CLF170007, CLF170008, CLF170009, CLF170010, CLF170011, CLF170012, CLF170013 exp February 2019
3	CLF170014, CLF170015, CLF170016 exp March 2019
4	CLF170017, CLF170018, CLF170019, exp April 2019
5	CLF170020, CLF170021, CLF170022 exp May 2019
6	CLF170035, CLF170036, CLF170037, CLF170038 exp August 2019
7	CLF170048, CLF170049, CLF170050, CLF170051, CLF170052 exp September 2019

Amount recalled

308112 bags

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

• Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx…
• Levofloxacin in 5% Dextrose Injection, 250 mg Levofloxacin (5 mg/mL) in 50 mL of 5%…
• Levetiracetam in 0.82% Sodium Chloride Injection, 500 mg per 100 mL (5 mg/mL), For…
• Levetiracetam in 0.75% Sodium Chloride Injection, 1000 mg per 100 mL (10 mg/mL), For…
• Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For…
• Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5%…

Where it was sold

• Nationwide

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

This product could cause temporary or reversible health problems — stop using it.