FDA recall D-0965-2015

SCA Pharmaceuticals · Class II · drug

Product

Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat sealed bag, RX only; Compounded for Office Use by SCA Pharmaceuticals, Little Rock, AR (877 ) 550-5059 Bar Code 88888-7720-16

Reason for recall

Presence of particulate.

Distribution

IN, AR, MO, MN

Key facts

Status
Terminated
Initiation date
2015-02-24
Report date
2015-04-29
Termination date
2016-12-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0965-2015