Drug product
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag, Each bag contains 9.3 mEq Ca++ Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0510-30
D-0067-2018
Product summary
- Event
- Event 78320
- Status
- Terminated
- Classification
- Class II
- Quantity
- 76 bags
- Official record key
drug-enforcement:D-0067-2018
Official wording
Reason: Lack Of Assurance Of Sterility.
Code information: Lot: 20170920@20 BUD: 11/09/2017
Distribution pattern: Nationwide in the United States
Derived failure modes
-
Sterility assurance
Lack Of Assurance Of Sterility