PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: November 17, 2021 Initiated: October 14, 2021 #D-0228-2022

Product Description

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

Details

Units Affected
49
Distribution
Distributed to two distributors located in AZ and MO
Location
Camarillo, CA

Frequently Asked Questions

What product 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. Recalled by Golden State Medical Supply Inc.. Units affected: 49.
Why was this product recalled?
Failed Excipient Specification; product manufactured using an excipient found to be OOS for conductivity
Which agency issued this recall?
This recall was issued by the FDA Drug on November 17, 2021. Severity: Moderate. Recall number: D-0228-2022.