Recalls / Class II
Class IID-0125-2018
Product
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
- Affected lot / code info
- Lot # 544637A
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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1090 Horsham Rd, North Wales, Pennsylvania 19454-1505
Distribution
- Quantity
- 5,374 blister cards/28 tablets
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2017-11-20
- FDA classified
- 2017-12-20
- Posted by FDA
- 2017-12-27
- Terminated
- 2018-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0125-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.