FDAClass IINovember 10, 2021

Dr. Reddy's Ezetimibe and Simvastatin Tablets recall

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

Why was Dr. Reddy's Ezetimibe and Simvastatin Tablets recalled?

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

a) L100160, exp 01/2023 b) L100249, exp 01/2023 c) L100250, exp 01/2023

Product
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
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
a) 3,444 bottles b) 469 bottles c) 142 bottles
Distribution
Nationwide in the US
Recall date
November 10, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls