Why it was recalled
Presence of Foreign Substance: Presence of stainless steel particles.
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.
Lot numbers, UPCs & expiration codes
Lot #: DZ4056, Expiry: 11/2015; Lot # DZ4057, Expiry: 01/2016
Where it was sold
Nationwide including Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1350-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 22, 2014
- FDA report date
- Jun 4, 2014
- Quantity
- 22,818 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz, Inc
Original FDA data
Every field from FDA enforcement report D-1350-2014, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68360
- Address
- 506 Carnegie Ctr Ste 400
- Code information
- Lot #: DZ4056, Expiry: 11/2015; Lot # DZ4057, Expiry: 01/2016
- Postal code
- 08540-6243
- Report date
- Jun 4, 2014
- Product type
- Drugs
- Recall number
- D-1350-2014
- Classification
- Class II
- Recalling firm
- Sandoz, Inc
- Product quantity
- 22,818 Bottles
- Termination date
- Feb 5, 2015
- Reason for recall
- Presence of Foreign Substance: Presence of stainless steel particles.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide including Puerto Rico.
- Recall initiation date
- May 22, 2014
- Initial firm notification
- Letter
- Center classification date
- May 23, 2014