Class II
Terminated
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
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- November 20, 2017
- Posted
- December 27, 2017
- Recall Number
- D-0125-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,374 blister cards/28 tablets
- Firm Location
- North Wales, PA, United States
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
Nationwide in the USA and Puerto Rico
Lot / Code Info
Lot # 544637A
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