Drug product
Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Service Code 2K5298, NDC# 61553-0298-48, Total Volume 100.00 mL incorrectly labeled as 102.50 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
D-0909-2017
Product summary
- Event
- Event 77191
- Status
- Terminated
- Classification
- Class III
- Quantity
- 192 bags
- Official record key
drug-enforcement:D-0909-2017
Official wording
Reason: Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Code information: Lot Numbers: 163640146S, 3/30/2017; 170020187S, 4/3/2017; 170100120S, 4/11/2017; 170200117S, 4/23/2017; 170340009S, 5/6/2017
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Not Elsewhere Classified: Incorrect