FDA recall D-0228-2022

Golden State Medical Supply Inc. · Class II · drug

Product

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

Reason for recall

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

Distribution

Distributed to two distributors located in AZ and MO

Key facts

Status: Terminated
Initiation date: 2021-10-14
Report date: 2021-11-17
Termination date: 2022-11-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Camarillo, CA, United States

Primary source

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