FDA-Drug2021-11-17Class II

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

Golden State Medical Supply Inc.
Hazard

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

Sold states
Distributed to two distributors located in AZ and MO
Affected count
49
Manufactured in
5187 Camino Ruiz, N/A, Camarillo, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0228-2022

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