Drug product
Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service Code 2K5856, NDC# 61553-0856-48, Total Volume 100.00 mL incorrectly labeled as 105.00 mL, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141
D-0907-2017
Product summary
- Event
- Event 77191
- Status
- Terminated
- Classification
- Class III
- Quantity
- 143 bags
- Official record key
drug-enforcement:D-0907-2017
Official wording
Reason: Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Code information: Lot Numbers: 163640167M, 3/21/2017; 170050171M, 3/28/2017; 170070172M, 3/31/2017;170190235M, 4/11/2017; 170200120M, 4/14/2017; 170230115M, 4/15/2017; 170390059D, 5/10/2017;
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Not Elsewhere Classified: Incorrect