Drug recall D-0462-2025
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
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.
Lots and codes
Lot #: 17240195, Exp 01/31/2026.
Recall details
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Quantity
- 6,759 Con - 90 bottle pack
- Distribution
- Nationwide USA and PR
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 19, 2025
Related products
- ezetimibe and simvastatin – drug information
- NDC 68462-323 ezetimibe and simvastatin · Ezetimibe 10 mg/1; Simvastatin 40 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-321 ezetimibe and simvastatin · Ezetimibe 10 mg/1; Simvastatin 10 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-324 ezetimibe and simvastatin · Ezetimibe 10 mg/1; Simvastatin 80 mg/1 · Glenmark Pharmaceuticals Inc., USA
- NDC 68462-322 ezetimibe and simvastatin · Ezetimibe 10 mg/1; Simvastatin 20 mg/1 · Glenmark Pharmaceuticals Inc., USA