D-0227-2022 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
- a) 101 b) 145 bottles
Product Description
Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets, Rx only, Manufactured by Dr. Reddy's Laboratories LA LLC Shreveport, LA 71106 USA, Packaged by GSMS, Incorporated Camarillo, CA 93012 USA; NDC: a) 51407-192-90, b) 51407-192-05
Reason for Recall
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Distribution Pattern
Distributed to two distributors located in AZ and MO
Code Information
a) Lot: GS038610, Exp: 01/2023; b) GS038891, Exp: 1/2023