Why it was recalled
Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
Product description
Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.
Lot numbers, UPCs & expiration codes
Lot 25394DK, exp. 01/2015
Where it was sold
Nationwide
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-851-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 20, 2013
- FDA report date
- Aug 14, 2013
- Quantity
- 340,600 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira, Inc.
Original FDA data
Every field from FDA enforcement report D-851-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 65300
- Address
- 600 N Field Dr Bldg J45
- Code information
- Lot 25394DK, exp. 01/2015
- Postal code
- 60045
- Report date
- Aug 14, 2013
- Product type
- Drugs
- Recall number
- D-851-2013
- Classification
- Class II
- Recalling firm
- Hospira, Inc.
- Product quantity
- 340,600 vials
- Termination date
- Oct 28, 2014
- Reason for recall
- Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles found in a lot which preceded the recalled lot
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.
- Distribution pattern
- Nationwide
- Recall initiation date
- May 20, 2013
- Initial firm notification
- Letter
- Center classification date
- Aug 7, 2013