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
D-0581-2024
Product summary
- Event
- Event 94754
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 13,752 bottles
- Official record key
drug-enforcement:D-0581-2024
Official wording
Reason: Failed Impurities/Degradation Specifications: Related Substances
Code information: Lot#: C2302598, Exp 2/29/2025
Distribution pattern: OH, MS
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications