Why it was recalled
Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Product description
0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67
Lot numbers, UPCs & expiration codes
Lot# 44-110-JT; Exp 08/16
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-0490-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 7, 2015
- FDA report date
- Apr 29, 2015
- Quantity
- 128,050 ADD-Vantage flexible containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0490-2015, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70925
- Address
- 600 N Field Dr
- Code information
- Lot# 44-110-JT; Exp 08/16
- Postal code
- 60045-4835
- Report date
- Apr 29, 2015
- Product type
- Drugs
- Recall number
- D-0490-2015
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 128,050 ADD-Vantage flexible containers
- Termination date
- Nov 4, 2016
- Reason for recall
- Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira Inc., Lake Forest, IL, 60045, NDC: 0409-7101-67
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 7, 2015
- Initial firm notification
- Letter
- Center classification date
- Apr 17, 2015