Drug 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
D-0976-2017
Product summary
- Event
- Event 77600
- Status
- Terminated
- Classification
- Class II
- Quantity
- 221 bags
- Official record key
drug-enforcement:D-0976-2017
Official wording
Reason: Lack of sterility assurance
Code information: Lot #: 20170509@2, Exp 6/23/2017; 20170524@22, Exp 7/8/2017; 20170602@10, Exp 7/17/2017; 20170609@27, Exp 7/24/2017
Distribution pattern: LA, PA, NY, WI
Derived failure modes
-
Sterility assurance
Lack of sterility