Drug 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.
D-1350-2014
Product summary
- Firm
- Sandoz, Inc
- Event
- Event 68360
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22,818 Bottles
- Official record key
drug-enforcement:D-1350-2014
Official wording
Reason: Presence of Foreign Substance: Presence of stainless steel particles.
Code information: Lot #: DZ4056, Expiry: 11/2015; Lot # DZ4057, Expiry: 01/2016
Distribution pattern: Nationwide including Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance