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.
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
Lot numbers, UPCs & expiration codes
Lot # 544637A
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0125-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 20, 2017
- FDA report date
- Dec 27, 2017
- Quantity
- 5,374 blister cards/28 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA
Original FDA data
Every field from FDA enforcement report D-0125-2018, exactly as published.
Show all FDA fields
- City
- North Wales
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 78590
- Address
- 1090 Horsham Rd
- Code information
- Lot # 544637A
- Postal code
- 19454-1505
- Report date
- Dec 27, 2017
- Product type
- Drugs
- Recall number
- D-0125-2018
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA
- Product quantity
- 5,374 blister cards/28 tablets
- Termination date
- Jun 21, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Nov 20, 2017
- Initial firm notification
- Letter
- Center classification date
- Dec 20, 2017