FDA recall D-0147-2021

SCA Pharmaceuticals · Class III · drug

Product

Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205

Reason for recall

Subpotency: Out-of-specification stability test result for low potency was obtained.

Distribution

Product was distributed to three hospitals in MO & LA.

Key facts

Status
Terminated
Initiation date
2020-11-20
Report date
2020-12-23
Termination date
2021-06-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0147-2021