Why it was recalled
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Product description
5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48
Lot numbers, UPCs & expiration codes
Lot #: 11-161-JT, Exp 11/13
Where it was sold
Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
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-615-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 4, 2012
- FDA report date
- Jul 3, 2013
- Quantity
- 74,256 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-615-2013, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 61918
- Address
- 275 N Field Dr
- Code information
- Lot #: 11-161-JT, Exp 11/13
- Postal code
- 60045-2579
- Report date
- Jul 3, 2013
- Product type
- Drugs
- Recall number
- D-615-2013
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 74,256 units
- Termination date
- Jul 17, 2015
- Reason for recall
- Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7926-48
- Distribution pattern
- Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
- Recall initiation date
- May 4, 2012
- Initial firm notification
- Letter
- Center classification date
- Jun 21, 2013