Recalls / Class II
Class IID-0334-2015
Product
0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7984-11
- Affected lot / code info
- Lot #: 42-306-C6
Why it was recalled
Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 375 N Field Dr, N/A, Lake Forest, Illinois 60045-2513
Distribution
- Quantity
- 30840 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-12-22
- FDA classified
- 2015-01-07
- Posted by FDA
- 2015-01-14
- Terminated
- 2015-07-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0334-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.