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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 containin

DrugsSource: FDA (drug) · Date: 2026-06-24

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
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 / hazard
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Classification
Class II
Status
Ongoing
Distribution / sold at
USA Nationwide.
Recall initiated
2026-05-27
Code info
Lot #: 20240411, Exp: 6/30/2026; 20250252, Exp: 3/31/2027
Voluntary mandated
Voluntary: Firm initiated
City
Elmwood Park
State
NJ
Country
United States
Event id
99101
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