FDA recall D-1362-2014

Product

Midazolam 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69.

Reason for recall

Superpotent Drug: Product contains twice the stated amount of midazolam.

Distribution

IN

Key facts

Status

Terminated

Initiation date

2014-03-26

Report date

2014-06-18

Termination date

2014-07-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Noblesville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1362-2014