Eszopiclone Tablet, Coated
FDA Recall NDC 55111-619
Latest: Class III · Status: Ongoing · Initiated Jun 04, 2024 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Eszopiclone (NDC 55111-619). A significant event, classified as Class III, was initiated on Jun 04, 2024 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Related Substances"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Impurities/Degradation Specifications: Related Substances
Jun 04, 2024
Jul 10, 2024
13,752 bottles
Recall Profile & Regulatory Data
Event ID
94754
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
OH, MS
Product Description
Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30
Batch or Lot Expiration Information
Lot# : C2302598, Exp 2/29/2025
Affected Packages Involved in this Recall
55111-629-30Eszopiclone
55111-629-01Eszopiclone
55111-629-05Eszopiclone
55111-619-30Eszopiclone
55111-619-90Eszopiclone
55111-619-01Eszopiclone
55111-619-05Eszopiclone
55111-619-79Eszopiclone
55111-619-09Eszopiclone
55111-617-30Eszopiclone
55111-617-90Eszopiclone
55111-617-01Eszopiclone
55111-617-05Eszopiclone
55111-617-79Eszopiclone
55111-617-09Eszopiclone
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.
