FDA recall D-0078-2023

OurPharma LLC · Class II · drug

Product

FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01

Reason for recall

Underfilled units.

Distribution

MO

Key facts

Status
Terminated
Initiation date
2022-11-29
Report date
2022-12-21
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-0078-2023