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
D-0979-2017
Product summary
- Event
- Event 77600
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 bags
- Official record key
drug-enforcement:D-0979-2017
Official wording
Reason: Lack of sterility assurance
Code information: Lot #: 20170511@58, Exp 6/25/2017
Distribution pattern: LA, PA, NY, WI
Derived failure modes
-
Sterility assurance
Lack of sterility