Drug 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
D-1174-2022
Product summary
- Event
- Event 90444
- Status
- Terminated
- Classification
- Class II
- Quantity
- 168690 Tablets
- Official record key
drug-enforcement:D-1174-2022
Official wording
Reason: Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Code information: Lot #: BEK2009A Exp: 11/2023
Distribution pattern: Distributed Nationwide and Puerto Rico.
Derived failure modes
-
Unknown
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.