Escitalopram Tablet
FDA Recall NDC 68180-137
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 Escitalopram (NDC 68180-137). A significant event, classified as Class III, was initiated on Mar 24, 2016 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Labeling: Incorrect or Missing Lot and/or Expiration Date"
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 III Terminated
Labeling: Incorrect or Missing Lot and/or Expiration Date
Mar 24, 2016
Sep 28, 2016
3,192 bottles (319,200 tablets)
Recall Profile & Regulatory Data
Event ID
74944
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 15, 2017
Product Description
Escitalopram Tablets USP 20 mg, 100-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD, 21202, Manufactured by: Lupin Limited, Goa 403 722, India, NDC 68180-136-01
Batch or Lot Expiration Information
Lot# G510086; Exp. 11/17
Affected Packages Involved in this Recall
68180-137-01Product
68180-137-06Product
68180-135-01Product
68180-136-01Product
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.
