Reported Dec 27, 2017 · Terminated
Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx…
Teva Pharmaceuticals USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 1090 Horsham Rd · North Wales, PA · 19454-1505
Is this the product you have?
- Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only
- Manufactured byWarner Chilcott Company, LLC Fajardo
- Puerto Rico 00738Distributed
- byActavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28
- Lot codes and dates
- Lot # 544637A
- Amount recalled
- 5,374 blister cards/28 tablets
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
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