D-0581-2024 Class III Ongoing
FDA drug recall D-0581-2024 was initiated by Dr. Reddy's Laboratories, Inc. on June 4, 2024 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Related Substances The recall status is ongoing. Affected quantity: 13,752 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 10, 2024
- Initiation Date
- June 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,752 bottles
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
Distribution Pattern
OH, MS
Code Information
Lot#: C2302598, Exp 2/29/2025