Recalls / Class II
Class IID-1174-2022
Product
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
- Brand name
- Eszopiclone
- Generic name
- Eszopiclone
- Active ingredient
- Eszopiclone
- Route
- Oral
- NDCs
- 33342-299, 33342-300, 33342-301
- FDA application
- ANDA202929
- Affected lot / code info
- Lot #: BEK2009A Exp: 11/2023
Why it was recalled
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, New Jersey 08536-0009
Distribution
- Quantity
- 168690 Tablets
- Distribution pattern
- Distributed Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2022-06-16
- FDA classified
- 2022-07-05
- Posted by FDA
- 2022-07-13
- Terminated
- 2024-03-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1174-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.