Glenmark Pharmaceuticals Inc., Usa: Alyacen 7/7/7, Norethindrone And Ethinyl Estradiol Tablets Usp, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 Mg/0.0.35mg, 3 Blister Cards Each Containing 28 Ta...
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product
- Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 day regimen, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India, Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430, NDC 68462-556-29
- Reason
- Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-05-27
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- USA Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/848db270-cf0b-474f-b464-a6a8ccc11739