FDA recall D-1566-2014

Product

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.

Reason for recall

Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.

Distribution

United States: TX, IL, MD, IN

Key facts

Status

Terminated

Initiation date

2014-04-21

Report date

2014-09-03

Termination date

2014-12-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Noblesville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1566-2014