Recalls / Class II
Class IID-1350-2014
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.
- Brand name
- Cefpodoxime Proxetil
- Generic name
- Cefpodoxime Proxetil
- Active ingredient
- Cefpodoxime Proxetil
- Route
- Oral
- NDCs
- 0781-5438, 0781-5439
- FDA application
- ANDA065462
- Affected lot / code info
- Lot #: DZ4056, Expiry: 11/2015; Lot # DZ4057, Expiry: 01/2016
Why it was recalled
Presence of Foreign Substance: Presence of stainless steel particles.
Recalling firm
- Firm
- Sandoz, Inc
- Manufacturer
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 506 Carnegie Ctr Ste 400, Princeton, New Jersey 08540-6243
Distribution
- Quantity
- 22,818 Bottles
- Distribution pattern
- Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2014-05-22
- FDA classified
- 2014-05-23
- Posted by FDA
- 2014-06-04
- Terminated
- 2015-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1350-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.