US Drug Recall Register
Class II · Moderate risk Terminated Initiated Oct 14, 2021 (5 years ago)

Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity

What was recalled

Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC 51407-193-05

Recalling firm
Golden State Medical Supply Inc.
NDC code
51407-193-05
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0228-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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