Drug product
Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0833-40
D-1033-2017
Product summary
- Event
- Event 77770
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1033-2017
Official wording
Reason: Lack of Assurance of Sterility; product has the potential to leak.
Code information: Lots: 20170509@10 BUD: 7/23/2017
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility