Drug product
Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service Code 2K5824, NDC# 61553-0824-48, Total Volume 100.00 mL incorrectly labeled as 115.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
D-0906-2017
Product summary
- Event
- Event 77191
- Status
- Terminated
- Classification
- Class III
- Quantity
- 216 bags
- Official record key
drug-enforcement:D-0906-2017
Official wording
Reason: Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Code information: Lot Numbers: 70090135M, 2/27/2017; 170250101M, 3/15/2017; 170030011D, 4/4/2017; 170040078D, 4/5/2017; 170310012D, 5/2/2017; 170400046D, 5/11/2017;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Not Elsewhere Classified: Incorrect