FDA recall D-0172-2023

OurPharma LLC · Class III · drug

Product

FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01.

Reason for recall

Short Fill: Underfilled units.

Distribution

IL and MO

Key facts

Status
Terminated
Initiation date
2023-01-13
Report date
2023-02-01
Termination date
2024-09-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fayetteville, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0172-2023