FDA Drug recall D-0581-2024
Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd
- FDA Drug
- Class III
- ongoing
- Published 2024-07-10
On 2024-07-10 the FDA classified a Class III recall of Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd by Dr Reddy S Laboratories, citing failed Impurities/Degradation Specifications: Related Substances.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0581-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-06-04 |
| Published | 2024-07-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | MS, OH |
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
Failed Impurities/Degradation Specifications: Related Substances
Identifiers
| ndc | 55111-629-30 |
|---|---|
| ndc | 55111-629-01 |
| ndc | 55111-629-05 |
| ndc | 55111-619-30 |
| ndc | 55111-619-90 |
| ndc | 55111-619-01 |
| ndc | 55111-619-05 |
| ndc | 55111-619-79 |
| ndc | 55111-619-09 |
| ndc | 55111-617-30 |
| ndc | 55111-617-90 |
| ndc | 55111-617-01 |
| ndc | 55111-617-05 |
| ndc | 55111-617-79 |
| ndc | 55111-617-09 |
| code_info | Lot#: C2302598, Exp 2/29/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0581-2024%22
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