Drug product
ESTRADIOL, Tablet, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00555089902.
D-952-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 Tablets
- Official record key
drug-enforcement:D-952-2014
Official wording
Reason: Labeling: Label Mixup: ESTRADIOL, Tablet, 0.5 mg may have potentially been mislabeled as the following drug: NICOTINE POLACRILEX, GUM, 2 mg, NDC 00536302923, Pedigree: AD33897_28, EXP: 2/28/2014.
Code information: ESTRADIOL, Tablet, 0.5 mg has the following codes: Pedigree: AD30993_11, EXP: 5/9/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled