FDA recall D-0581-2024

Dr. Reddy's Laboratories, Inc. · Class III · drug

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

Reason for recall

Failed Impurities/Degradation Specifications: Related Substances

Distribution

OH, MS

Key facts

Status
Ongoing
Initiation date
2024-06-04
Report date
2024-07-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0581-2024