Teva Pharmaceuticals USA recalls Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx o…

Recall date

November 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0125-2018

FDA classification

Class II

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Nationwide in the USA and Puerto Rico

Why it was recalled

Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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