Duloxetine Capsule, Delayed Release
FDA Recall NDC 68180-296
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 Duloxetine (NDC 68180-296). A significant event, classified as Class III, was initiated on Nov 21, 2017 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Dissolution Specification"
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
Failed Dissolution Specification
Nov 21, 2017
Dec 06, 2017
111,648 units
Recall Profile & Regulatory Data
Event ID
78596
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Apr 15, 2019
Product Description
Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Goa 403 722 India, NDC 68180-295-06, UPC 368180295068
Batch or Lot Expiration Information
Lot# : G602051, Exp. 12/2017
Affected Packages Involved in this Recall
68180-294-07Product
68180-294-03Product
68180-294-09Product
68180-294-06Product
68180-295-06Product
68180-295-09Product
68180-295-03Product
68180-296-03Product
68180-296-06Product
68180-296-09Product
68180-297-06Product
68180-297-09Product
68180-297-03Product
3681802950Product
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.
