May 2014 FDA Recall Cefpodoxime Proxetil by Sandoz, Inc
D-1350-2014 - Presence of Foreign Substance
This Class II drug recall was voluntarily initiated by Sandoz, Inc on May 22, 2014 for the product Cefpodoxime Proxetil. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1350-2014
Presence of Foreign Substance: Presence of stainless steel particles.
05-22-2014
06-04-2014
22,818 Bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sandoz, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide including Puerto Rico.
02-05-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
