Paroxetine Tablet, Film Coated, Extended Release
FDA Recall NDC 68180-645
Latest: Class III · Status: Terminated · Initiated Jun 22, 2017 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Paroxetine (NDC 68180-645). A significant event, classified as Class III, was initiated on Jun 22, 2017 by Lupin Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 month long term stability study."
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 Specifications: out of specification observed in dissolution testing at 3 month long term stability study.
Jun 22, 2017
Jul 19, 2017
12480 bottles
Recall Profile & Regulatory Data
Event ID
77606
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Lupin Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jan 17, 2019
Product Description
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
Affected Packages Involved in this Recall
68180-647-06Paroxetine
68180-647-01Paroxetine
68180-647-02Paroxetine
68180-647-03Paroxetine
68180-646-06Paroxetine
68180-646-01Paroxetine
68180-646-02Paroxetine
68180-646-03Paroxetine
68180-645-06Paroxetine
68180-645-01Paroxetine
68180-645-02Paroxetine
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.
