Drug product
Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28
D-0125-2018
Product summary
- Event
- Event 78590
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,374 blister cards/28 tablets
- Official record key
drug-enforcement:D-0125-2018
Official wording
Reason: Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Code information: Lot # 544637A
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect