Why it was recalled
Failed Impurities/Degradation Specifications: Related Substances
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: C2302598, Exp 2/29/2025
Where it was sold
OH, MS
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0581-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jun 4, 2024
- FDA report date
- Jul 10, 2024
- Quantity
- 13,752 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0581-2024, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94754
- Address
- 107 College Rd E
- Code information
- Lot#: C2302598, Exp 2/29/2025
- Postal code
- 08540-6623
- Report date
- Jul 10, 2024
- Product type
- Drugs
- Recall number
- D-0581-2024
- Classification
- Class III
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 13,752 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications: Related Substances
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- OH, MS
- Recall initiation date
- Jun 4, 2024
- Center classification date
- Jul 2, 2024