Drug 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
D-0588-2026
Product summary
- Event
- Event 99101
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0588-2026
Official wording
Reason: Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Code information: Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
Distribution pattern: USA Nationwide.
Derived failure modes
-
Potency or specification failure
out-of-specification