D-0462-2025 Class III Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- June 18, 2025
- Initiation Date
- May 19, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,759 Con - 90 bottle pack
Product Description
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
Reason for Recall
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.
Distribution Pattern
Nationwide USA and PR
Code Information
Lot #: 17240195, Exp 01/31/2026.