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FDAFDA · Food and drugs·Recall number D-0083-2022

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA

Published November 10, 2021 · Recall initiated: October 5, 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; product manufactured using an excipient found to be OOS for conductivity

What to do

Voluntary: Firm initiated · Letter

Recall details

Brand
EZETIMIBE AND SIMVASTATIN
Manufacturer
Dr. Reddy's Laboratories, Inc.
Distributor
Nationwide in the US
UPC
0343598745909
Lot
a) L100160, exp 01/2023 b) L100249, exp 01/2023 c) L100250, exp 01/2023
Risk classification
Class II
Area (FDA)
drug
Country
United States

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