FDA recall D-1012-2017

Product

fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0229-05

Reason for recall

Lack of Assurance of Sterility; product has the potential to leak.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-07-14

Report date

2017-08-02

Termination date

2019-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1012-2017