FDA recall D-0874-2017

Product

fentaNYL (as citrate) in 100mL 0.9% Sodium Chloride injectable,20 mcg per mL, Single Dose Container bag, (Total fentanyl Dose 2,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-203-32

Reason for recall

Lack of assurance of sterility: Product bags leaking at seam.

Distribution

Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2017-05-18

Report date

2017-06-07

Termination date

2018-03-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0874-2017