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…
| Source | FDA · Drugs |
|---|---|
| Date | 2026-06-24 |
| 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 / hazard | Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities. |
| Classification | Class II |
| Official notice | — |
| Record ID | fda-drug:D-0588-2026 |