Recalls / Class II
Class IID-1096-2014
Product
0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-09
- Affected lot / code info
- Lot 34-609-FW; Exp 10/15
Why it was recalled
Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, which was identified during a retain sample visual inspection.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 603,768 bags
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-02-11
- FDA classified
- 2014-03-03
- Posted by FDA
- 2014-03-12
- Terminated
- 2015-03-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1096-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.