D-0125-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 27, 2017
- Initiation Date
- November 20, 2017
- Termination Date
- June 21, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,374 blister cards/28 tablets
Product Description
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
Reason for Recall
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Lot # 544637A