Recalls / Class II
Class IID-243-2013
Product
0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045
- Affected lot / code info
- Lot #: 22-028-JT Exp 04/14
Why it was recalled
Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.
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
- 624,240 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-02-18
- FDA classified
- 2013-04-04
- Posted by FDA
- 2013-04-10
- Terminated
- 2015-04-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-243-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.