Recalls / Class II
Class IID-1240-2015
Product
0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
- Affected lot / code info
- Lot #: 49-084-JT; 49-119-JT
Why it was recalled
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 314600 bags
- Distribution pattern
- United States
Timeline
- Recall initiated
- 2015-07-02
- FDA classified
- 2015-07-15
- Posted by FDA
- 2015-07-22
- Terminated
- 2016-11-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1240-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.