Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous…

Is this the product you have?

• Levofloxacin in 5% Dextrose Injection, 500 mg Levofloxacin (5 mg/mL) in 100 mL of 5% Dextrose, For Intravenous Infusion, Rx only
• Manufactured ByAurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-244-47

Lot codes and dates

5 of 5 products

Products covered by this recall

#	Product as published
1	CLF160008, CLF160009, CLF160010, CLF160011, exp June 2018
2	CLF160015, CLF160016 , CLF160017, exp August 2018
3	CLF170001 exp December 2018
4	CLF170023, CLF170024, exp May 2019
5	CLF170039, CLF170040, CLF170041, CLF170042, CLF170043, CLF170044, CLF170045, CLF170046, CLF170047 exp August 2019

Amount recalled

308472 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, 750 mg Levofloxacin (5 mg/mL) in 150 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.