Drug recall D-0227-2022

Class II Terminated reported Nov 17, 2021

Product

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

Lots and codes

a) Lot: GS038610, Exp: 01/2023; b) GS038891, Exp: 1/2023

Recall details

Recalling firm
Golden State Medical Supply Inc., Camarillo, CA
Quantity
a) 101 b) 145 bottles
Distribution
Distributed to two distributors located in AZ and MO
Type
Voluntary: Firm initiated
Recall initiated
October 14, 2021
Terminated
November 10, 2022

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