FDA recall D-0976-2017

Product

Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 10 mMol (14.67 mEq K+) Total Approximate Volume 254 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0840-40

Reason for recall

Lack of sterility assurance

Distribution

LA, PA, NY, WI

Key facts

Status

Terminated

Initiation date

2017-06-21

Report date

2017-07-19

Termination date

2019-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0976-2017