FDA Recall D-0581-2024
Dr. Reddy's Laboratories, Inc. · Princeton, NJ
Class III Ongoing 709 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Recall record
- Recall number
D-0581-2024- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- N/A
- Distribution
- OH, MS
- Recall initiated
- 2024-06-04
- Classified by FDA Center
- 2024-07-02
- FDA published
- 2024-07-10
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Firm location
- Princeton, NJ
Drug identification
- Brand name(s)
- ESZOPICLONE
- Generic name(s)
- ESZOPICLONE
- Manufacturer(s)
- Dr. Reddy's Laboratories Limited
- NDC(s)
55111-617, 55111-629, 55111-619- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.