FDAClass IIIJuly 10, 2024

Eszopiclone Tablets recall: Impurity Out of Spec

Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30

Why was Eszopiclone Tablets recalled?

Failed Impurities/Degradation Specifications: Related Substances

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Lot#: C2302598, Exp 2/29/2025

Product
Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30
Recalling firm
Dr. Reddy's Laboratories, Inc.
Quantity
13,752 bottles
Distribution
OH, MS
Recall date
July 10, 2024
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
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