FDA-Drug2014-09-03Class I
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48.
Pharmakon Pharmaceuticals
Hazard
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Sold states
United States: TX, IL, MD, IN
Affected count
10/50 mL bags, 40/100 mL bags
Manufactured in
14450 Getz Rd, N/A, Noblesville, IN, United States
Products
Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1566-2014Don't want to check this manually?
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