June 2017 FDA Recall Paroxetine by Lupin Pharmaceuticals Inc.
D-0974-2017 - Failed Dissolution Specifications
This Class III drug recall was voluntarily initiated by Lupin Pharmaceuticals Inc. on June 22, 2017 for the product Paroxetine. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0974-2017
Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
06-22-2017
07-19-2017
12480 bottles
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 in the USA
01-17-2019
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC: 68180-647-06
Batch or Lot Expiration Information
Lot# Lots: H605712, H605711, H605710, EXP November 2018; H702255, H702202 EXP March 2019
