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Glenmark Pharmaceuticals Inc., USA: Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28

DrugsSource: FDA (drug) · Date: 2025-10-22

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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
Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only, 28 day Regimen, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA., Mahwah, NJ, 07430, NDC 68462-318-29.
Reason / hazard
Failed Impurities/Degradation Specifications
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide.
Recall initiated
2025-09-03
Code info
Batch number 20230733, Exp Date: October 2025
Product quantity
26,928 packs
Voluntary mandated
Voluntary: Firm initiated
City
Mahwah
State
NJ
Country
United States
Event id
97547
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