Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only, Manufactured By: Aurobindo…

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• Linezolid Injection 600 mg per 300 mL (2 mg/mL) For Intravenous Administration, Rx only
• Manufactured ByAurobindo Pharma Limited IDA Pashamylaram - 502307, India, Manufactured for AuroMedics Pharma, LLC, NDC 55150-242-51

Lot codes and dates

9 of 9 products

Products covered by this recall

#	Product as published
1	CLZ160001, CLZ160002, CLZ160003, CLZ160004 exp July 2018
2	CLZ160005, CLZ160006, CLZ160008, CLZ160009, CLZ160010 and CLZ160012, exp August 2018
3	CLZ160013, CLZ160014, CLZ160015, CLZ160016, exp October 2018
4	CLZ160017, CLZ160018, CLZ160019, CLZ160021, CLZ160022, CLZ160023, exp November 2018
5	CLZ170001, CLZ170002, CLZ170003, CLZ170004, CLZ170005, CLZ170006, exp March 2019
6	CLZ170007, CLZ170008, CLZ170009, CLZ170010, exp May 2019
7	CLZ170011, CLZ170012, exp June 2019
8	CLZ170013, CLZ170014, CLZ170015, CLZ170016, exp, September 2019
9	CLZ170017, exp October 2019

Amount recalled

395150 bags

This recall covers 7 products

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

• 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%…
• 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.