Drug 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.
D-0021-2026
Product summary
- Event
- Event 97547
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 26,928 packs
- Official record key
drug-enforcement:D-0021-2026
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Batch number 20230733, Exp Date: October 2025
Distribution pattern: US Nationwide.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications