Paroxetine Tablet, Film Coated
FDA Recall NDC 68382-099
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Paroxetine (NDC 68382-099). A significant event, classified as Class II, was initiated on Nov 20, 2017 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets"
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 II Terminated
Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
Nov 20, 2017
Dec 06, 2017
19812 bottles
Recall Profile & Regulatory Data
Event ID
78612
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 01, 2020
Product Description
Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC 68382-099-10) count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534
Batch or Lot Expiration Information
Lot# a) Z701308, b) Z701309, c) Z701310 exp April 2019
Affected Packages Involved in this Recall
68382-097-16Product
68382-097-01Product
68382-097-05Product
68382-097-10Product
68382-097-06Product
68382-098-06Product
68382-098-16Product
68382-098-01Product
68382-098-05Product
68382-098-10Product
68382-099-06Product
68382-099-16Product
68382-099-01Product
68382-099-05Product
68382-099-10Product
68382-001-06Product
68382-001-16Product
68382-001-01Product
68382-001-05Product
68382-001-10Product
Class II Terminated
Presence of Foreign tablets/capsules: risperidone Tablets were found in bottle of paroxetine Tablets
Aug 18, 2017
Sep 20, 2017
44800 bottles
Recall Profile & Regulatory Data
Event ID
77963
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within United States
Termination Date
Jan 06, 2020
Product Description
Paroxetine tablets USP, 30mg, 30-count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA, Inc., Pennington, NJ 08534, NDC 68382-099-06, UPC 3 6838209906 8
Batch or Lot Expiration Information
Lot# : Z701133, Exp 03/19
Affected Packages Involved in this Recall
68382-097-16Product
68382-097-01Product
68382-097-05Product
68382-097-10Product
68382-097-06Product
68382-098-06Product
68382-098-16Product
68382-098-01Product
68382-098-05Product
68382-098-10Product
68382-099-06Product
68382-099-16Product
68382-099-01Product
68382-099-05Product
68382-099-10Product
68382-001-06Product
68382-001-16Product
68382-001-01Product
68382-001-05Product
68382-001-10Product
6838209906Product
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.
