Recalls / Class II
Class IID-0490-2015
Product
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
- Brand name
- Sodium Chloride
- Generic name
- Sodium Chloride
- Active ingredient
- Sodium Chloride
- Route
- Intravenous
- NDCs
- 0409-7101, 0409-7132
- FDA application
- NDA019465
- Affected lot / code info
- Lot# 44-110-JT; Exp 08/16
Why it was recalled
Lack of Sterility Assurance: The product has the potential to leak at the administrative port.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr, Lake Forest, Illinois 60045-4835
Distribution
- Quantity
- 128,050 ADD-Vantage flexible containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-04-07
- FDA classified
- 2015-04-17
- Posted by FDA
- 2015-04-29
- Terminated
- 2016-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0490-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.