Cefpodoxime Proxetil Tablet, Film Coated
FDA Recall NDC 0781-5439
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 Cefpodoxime Proxetil (NDC 0781-5439). A significant event, classified as Class II, was initiated on May 22, 2014 by Sandoz Inc. The reported reason for this action was: "Presence of Foreign Substance: Presence of stainless steel particles."
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 Substance: Presence of stainless steel particles.
May 22, 2014
Jun 04, 2014
22,818 Bottles
Recall Profile & Regulatory Data
Event ID
68360
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sandoz, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide including Puerto Rico.
Termination Date
Feb 05, 2015
Product Description
Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20.
Batch or Lot Expiration Information
Lot# : DZ4056, Expiry: 11/2015
Lot# DZ4057, Expiry: 01/2016
Affected Packages Involved in this Recall
0781-5438-20Product
0781-5438-01Product
0781-5439-20Product
0781-5439-01Product
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.
