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
Reported: December 27, 2017 Initiated: November 20, 2017 #D-0125-2018
Product Description
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
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.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 5,374 blister cards/28 tablets
- Distribution
- Nationwide in the USA and Puerto Rico
- Location
- North Wales, PA
Frequently Asked Questions
What product 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. Recalled by Teva Pharmaceuticals USA. Units affected: 5,374 blister cards/28 tablets.
Why was this product recalled? ▼
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 27, 2017. Severity: Moderate. Recall number: D-0125-2018.
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