Eszopiclone Tablet, Film Coated
FDA Recall NDC 33342-299
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Eszopiclone (NDC 33342-299). A significant event, classified as Class II, was initiated on Jun 16, 2022 by Macleods Pharmaceuticals Limited. The reported reason for this action was: "Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Jun 16, 2022
Jul 13, 2022
168690 Tablets
Recall Profile & Regulatory Data
Event ID
90444
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Macleods Pharma Usa Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide and Puerto Rico.
Termination Date
Mar 20, 2024
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
Batch or Lot Expiration Information
Lot# : BEK2009A Exp: 11/2023
Affected Packages Involved in this Recall
33342-299-07Product
33342-299-11Product
33342-299-44Product
33342-299-12Product
33342-300-11Product
33342-300-44Product
33342-300-12Product
33342-301-11Product
33342-301-44Product
33342-301-12Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
