Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (b...
FDA Recall #D-0125-2018 — Class II — November 20, 2017
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.
Recalling Firm
Teva Pharmaceuticals USA — North Wales, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5,374 blister cards/28 tablets
Distribution
Nationwide in the USA and Puerto Rico
Code Information
Lot # 544637A
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated