D-0228-2022 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 17, 2021
- Initiation Date
- October 14, 2021
- Termination Date
- November 10, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49
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
Distribution Pattern
Distributed to two distributors located in AZ and MO
Code Information
GS040048, Exp: 1/2023