Recalls / Class III
Class IIID-0581-2024
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
- Brand name
- Eszopiclone
- Generic name
- Eszopiclone
- Active ingredient
- Eszopiclone
- Route
- Oral
- NDCs
- 55111-617, 55111-629, 55111-619
- FDA application
- ANDA091024
- Affected lot / code info
- Lot#: C2302598, Exp 2/29/2025
Why it was recalled
Failed Impurities/Degradation Specifications: Related Substances
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 13,752 bottles
- Distribution pattern
- OH, MS
Timeline
- Recall initiated
- 2024-06-04
- FDA classified
- 2024-07-02
- Posted by FDA
- 2024-07-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0581-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.