FDA recall D-1018-2019

Advanced Pharma Inc. · Class II · drug

Product

fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, QS, Sterile single use bags, NDC: 42852-210-25 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

Reason for recall

Lack of Assurance of Sterility

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2019-03-13
Report date
2019-03-27
Termination date
2020-01-14
Voluntary/Mandated
Voluntary: Firm initiated
Location
Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1018-2019