Drug Enforcement D-0462-2025

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.

Status

Ongoing

Classification

Class III

Report Date

June 18, 2025

Termination Date

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Product Information

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
Product quantity
6,759 Con - 90 bottle pack
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.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide USA and PR

Location & Firm

Recalling firm
Glenmark Pharmaceuticals Inc., USA
Address
750 Corporate Dr

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0462-2025
Event ID
96884
Recall initiation date
May 19, 2025
Center classification date
June 10, 2025
Code info
Lot #: 17240195, Exp 01/31/2026.
More code info
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