Clozapine Tablet, Orally Disintegrating
FDA Recall NDC 0093-5376
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 Clozapine (NDC 0093-5376). A significant event, classified as Class II, was initiated on Sep 21, 2018 by Teva Pharmaceuticals Usa, Inc.. The reported reason for this action was: "Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing."
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 Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Sep 21, 2018
Oct 10, 2018
313 bottles
Recall Profile & Regulatory Data
Event ID
81068
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Teva Pharmaceuticals USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed nationwide in the USA
Termination Date
May 01, 2019
Product Description
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.
Batch or Lot Expiration Information
Lot# : 34034024B, Exp 02/20
Affected Packages Involved in this Recall
0093-5416-01Product
0093-5417-01Product
0093-5417-19Product
0093-5417-84Product
0093-5419-01Product
0093-5419-19Product
0093-5419-84Product
0093-5376-01Product
0093-5376-19Product
0093-5376-84Product
0093-5377-01Product
0093-5377-19Product
0093-5377-84Product
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.
