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FDAFDA · Food and drugs·Recall number D-0227-2022

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

Published November 17, 2021 · Recall initiated: October 14, 2021

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
EZETIMIBE AND SIMVASTATIN
Manufacturer
Golden State Medical Supply Inc.
Distributor
Distributed to two distributors located in AZ and MO
Lot
a) Lot: GS038610, Exp: 01/2023; b) GS038891, Exp: 1/2023
Risk classification
Class II
Area (FDA)
drug
Country
United States

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