Drug product
PROGESTERONE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591396401.
D-973-2014
Product summary
- Event
- Event 65690
- Status
- Terminated
- Classification
- Class II
- Quantity
- 99 Capsules
- Official record key
drug-enforcement:D-973-2014
Official wording
Reason: Labeling: Label Mixup:PROGESTERONE, Capsule, 100 mg may have potentially been mislabeled as the following drug: ASCORBIC ACID, Tablet, 250 mg, NDC 00904052260, Pedigree: AD73623_10, EXP: 5/30/2014.
Code information: PROGESTERONE, Capsule, 100 mg has the following codes: Pedigree: AD73611_4, EXP: 5/30/2014.
Distribution pattern: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Derived failure modes
-
Labeling or packaging
mislabeled