November 2017 FDA Recall Duloxetine by Lupin Pharmaceuticals Inc.
D-0097-2018 - Failed Dissolution Specification
This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on November 21, 2017 for the product Duloxetine. The FDA reported the reason for recall as failed dissolution specification. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0097-2018
Failed Dissolution Specification
11-21-2017
12-06-2017
111,648 units
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lupin Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
04-15-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
