Why it was recalled
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Product description
Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, NDC 33342-299-07
Lot numbers, UPCs & expiration codes
Lot #: BEK2009A Exp: 11/2023
Where it was sold
Distributed Nationwide and Puerto Rico.
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-1174-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 16, 2022
- FDA report date
- Jul 13, 2022
- Quantity
- 168690 Tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Macleods Pharma Usa Inc
Original FDA data
Every field from FDA enforcement report D-1174-2022, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90444
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230
- Code information
- Lot #: BEK2009A Exp: 11/2023
- Postal code
- 08536-0009
- Report date
- Jul 13, 2022
- Product type
- Drugs
- Recall number
- D-1174-2022
- Classification
- Class II
- Recalling firm
- Macleods Pharma Usa Inc
- Product quantity
- 168690 Tablets
- Termination date
- Mar 20, 2024
- Reason for recall
- Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, NDC 33342-299-07
- Distribution pattern
- Distributed Nationwide and Puerto Rico.
- Recall initiation date
- Jun 16, 2022
- Initial firm notification
- Letter
- Center classification date
- Jul 5, 2022