FDA recall D-0593-2016

Product

Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

Reason for recall

Subpotent drug.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-08-19

Report date

2016-02-03

Termination date

2017-05-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Noblesville, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0593-2016