Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Lim...
FDA Recall #D-0581-2024 — Class III — June 4, 2024
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: Related Substances
Recalling Firm
Dr. Reddy's Laboratories, Inc. — Princeton, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
13,752 bottles
Distribution
OH, MS
Code Information
Lot#: C2302598, Exp 2/29/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated