Paroxetine Tablet, Film Coated
FDA Recall NDC 68084-044
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 Paroxetine (NDC 68084-044). A significant event, classified as Class II, was initiated on Oct 24, 2017 by American Health Packaging. The reported reason for this action was: "Presence of Foreign Tablets/Capsules."
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.
Oct 24, 2017
Nov 29, 2017
74 cartons (cartons of 100 individual unit doses)
Recall Profile & Regulatory Data
Event ID
78490
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Amerisource Health Services
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jun 19, 2018
Product Description
Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01
Batch or Lot Expiration Information
Lot# Lot 172291
Affected Packages Involved in this Recall
68084-044-11Product
68084-044-01Product
68084-044-65Product
68084-045-11Product
68084-045-01Product
68084-046-11Product
68084-046-01Product
68084-047-11Product
68084-047-01Product
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.
