Amethyst recall: Labeling Error
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
Why was Amethyst recalled?
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 544637A
- 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
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 5,374 blister cards/28 tablets
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- December 27, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)