Recalls / Class II
Class IID-176-2013
Product
0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7972-08
- Affected lot / code info
- Lot 13-121-JT* * the lot number may be followed by 01
Why it was recalled
Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
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
- 56,854 Units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-02-12
- FDA classified
- 2013-02-28
- Posted by FDA
- 2013-03-06
- Terminated
- 2015-04-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-176-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.