FDA recall D-1565-2014

Pharmakon Pharmaceuticals · Class I · drug

Product

Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.

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-1565-2014