Drug product
ESTROPIPATE, Tablet, 0.75 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591041401.
D-963-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-963-2014
Official wording
Reason: Labeling: Label Mixup: ESTROPIPATE, Tablet, 0.75 mg may have potentially been mislabeled as the following drug: MESALAMINE DR, Capsule, 400 mg, NDC 00430075327, Pedigree: AD34934_1, EXP: 1/31/2014.
Code information: ESTROPIPATE, Tablet, 0.75 mg has the following codes: Pedigree: AD34934_4, EXP: 5/10/2014
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled