FDA recall D-0977-2017
SCA Pharmaceuticals · Class II · drug
Product
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-40
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-0977-2017