Drug product
CALCIUM POLYCARBOPHIL, Tablet, 625 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536430611.
D-939-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 Tablets
- Official record key
drug-enforcement:D-939-2014
Official wording
Reason: Labeling: Label Mixup: CALCIUM POLYCARBOPHIL, Tablet, 625 mg may have potentially been mislabeled as the following drug: CAFFEINE, Tablet, 100 mg (1/2 of 200 mg), NDC 24385060173, Pedigree: ADWA00002146, EXP: 5/31/2014.
Code information: CALCIUM POLYCARBOPHIL, Tablet, 625 mg has the following codes: Pedigree: AD73592_11, EXP: 5/31/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled