Drug product
Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Madya Pradesh, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-323-90
D-0462-2025
Product summary
- Event
- Event 96884
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 6,759 Con - 90 bottle pack
- Official record key
drug-enforcement:D-0462-2025
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Code information: Lot #: 17240195, Exp 01/31/2026.
Distribution pattern: Nationwide USA and PR
Derived failure modes
-
Potency or specification failure
Out of Specification