FDA recall D-0066-2018

Product

PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12

Reason for recall

Lack Of Assurance Of Sterility.

Distribution

Nationwide in the United States

Key facts

Status

Terminated

Initiation date

2017-10-19

Report date

2017-11-08

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-0066-2018