FDA recall D-0979-2017

SCA Pharmaceuticals · Class II · drug

Product

Potassium PHOSphate added to 0.9% Sodium Chloride 250 mL Bag 30 mMol (44 mEq K+) Total Approximate Volume 260 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0843-40

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-0979-2017