Paliperidone Tablet, Film Coated, Extended Release
FDA Recall NDC 0904-6937
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 Paliperidone (NDC 0904-6937). A significant event, classified as Class II, was initiated on Feb 28, 2022 by Major Pharmaceuticals. The reported reason for this action was: "Failed Dissolution Specifications"
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
Failed Dissolution Specifications
Feb 28, 2022
Mar 16, 2022
174 cartons
Recall Profile & Regulatory Data
Event ID
89681
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
The Harvard Drug Group
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Jun 08, 2023
Product Description
PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61
Batch or Lot Expiration Information
Lot# : N00522, Exp. Date 09/2022; N00618, Exp. Date 11/2022
Affected Packages Involved in this Recall
0904-6935-61Product
0904-6936-61Product
0904-6937-61Product
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.
