Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only,…

Is this the product you have?

• Levetiracetam in 0.54% Sodium Chloride Injection, 1,500 mg per 100 mL (15 mg/mL), For Intravenous Infusion Only
• Distributed ByAuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-248-47

Lot codes and dates

• • Lot/Batch #'s: CLV160004
  • CLV160005
  • and CLV160006 exp September 2018
  • CLV170011
  • CLV170015
  • CLV170016 exp June 2019

Amount recalled

67300 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…
• 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.