Why it was recalled
Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
Product description
Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04
Lot numbers, UPCs & expiration codes
18-099-DK
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-169-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 10, 2013
- FDA report date
- Mar 6, 2013
- Quantity
- 63,900 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira, Inc.
Original FDA data
Every field from FDA enforcement report D-169-2013, exactly as published.
Show all FDA fields
- City
- Rocky Mount
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 64083
- Address
- Hwy. 301 N. + 4285 North Wesleyan Blvd.
- Code information
- 18-099-DK
- Postal code
- 27804
- Report date
- Mar 6, 2013
- Product type
- Drugs
- Recall number
- D-169-2013
- Classification
- Class II
- Recalling firm
- Hospira, Inc.
- Product quantity
- 63,900 vials
- Termination date
- Oct 8, 2014
- Reason for recall
- Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Furosemide Injection USP (10 mg/mL), 4 mL in 5 mL Fliptop Vial, Rx only, Hospira Inc., Lake Forest, IL --- NDC 0409-6102-04
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 10, 2013
- Initial firm notification
- Letter
- Center classification date
- Feb 26, 2013