FDA recall D-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

Reason for recall

Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.

Distribution

Distributed Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2022-06-16

Report date

2022-07-13

Termination date

2024-03-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1174-2022