Recalls / Class II
Class IID-183-2013
Product
0.9% Sodium Chloride Injection USP, 100 mL Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7984-23,
- Affected lot / code info
- Lot Number 02-117-JT Exp. 02/13
Why it was recalled
Lack of Assurance of Sterility: There is the potential for 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
- 325,056 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-01-08
- FDA classified
- 2013-03-07
- Posted by FDA
- 2013-03-13
- Terminated
- 2015-05-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-183-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.