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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 21, 2018 · Data as of Sep 19, 5:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.