Drug product
PROGESTERONE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00032170801.
D-786-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 500 Capsules
- Official record key
drug-enforcement:D-786-2014
Official wording
Reason: Labeling: Label Mixup: PROGESTERONE, Capsule, 100 mg may be potentially mislabeled as the following drug: LEVOTHYROXINE SODIUM, Tablet, 12.5 mcg (1/2 of 25 mcg), NDC 00527134101, Pedigree: AD46265_40, EXP: 5/15/2014.
Code information: PROGESTERONE, Capsule, 100 mg has the following codes: Pedigree: AD46320_1, EXP: 5/15/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled