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
Reported: June 18, 2025 Initiated: May 19, 2025 #D-0462-2025
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.
Details
- Recalling Firm
- Glenmark Pharmaceuticals Inc., USA
- Units Affected
- 6,759 Con - 90 bottle pack
- Distribution
- Nationwide USA and PR
- Location
- Mahwah, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 6,759 Con - 90 bottle pack.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 18, 2025. Severity: Low. Recall number: D-0462-2025.
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