FDA-Drug2017-12-27Class II
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
Teva Pharmaceuticals USA
Hazard
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
5,374 blister cards/28 tablets
Manufactured in
1090 Horsham Rd, North Wales, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0125-2018Don't want to check this manually?
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