June 2024 FDA Recall Eszopiclone by Dr. Reddy's Laboratories, Inc.
D-0581-2024 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on June 4, 2024 for the product Eszopiclone. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed in OH, MS and the recall is currently ongoing.
Recall Number: D-0581-2024
Failed Impurities/Degradation Specifications: Related Substances
06-04-2024
07-10-2024
13,752 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
OH, MS
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : C2302598, Exp 2/29/2025
