Drug product
POTASSIUM ACID PHOSPHATE, Tablet, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00486111101.
D-917-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-917-2014
Official wording
Reason: Labeling: Label Mixup: POTASSIUM ACID PHOSPHATE, Tablet, 500 mg may have potentially been mislabeled as the following drug: predniSONE, Tablet, 20 mg, NDC 00591544301, Pedigree: AD56879_5, EXP: 5/21/2014.
Code information: POTASSIUM ACID PHOSPHATE, Tablet, 500 mg has the following codes: Pedigree: AD52778_34, EXP: 5/20/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled