Drug product
Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Service Code 2K5287, NDC# 61553-0287-48, Total Volume 100.00 mL incorrectly labeled as106.67 mL, Rx Only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 74478
D-0912-2017
Product summary
- Event
- Event 77191
- Status
- Terminated
- Classification
- Class III
- Quantity
- 48 bags
- Official record key
drug-enforcement:D-0912-2017
Official wording
Reason: Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.
Code information: Lot Numbers: 170100124S, 4/11/2017; 170390015S, 5/10/2017
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Not Elsewhere Classified: Incorrect