Recalls / Class II
Class IID-608-2013
Product
0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02
- Affected lot / code info
- Lot #: 16-031-JT*, Exp 1APR2014; Note the * may be followed by 01 or 02
Why it was recalled
Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the administrative port of the primary container.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 676,872 containers
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-06-06
- FDA classified
- 2013-06-20
- Posted by FDA
- 2013-06-26
- Terminated
- 2015-05-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-608-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.