Recalls / Class I
Class ID-836-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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 #: 25-037-JT*, Exp 1JAN2015, Note: the lot number may be followed by 01 or 90
Why it was recalled
Presence of Particulate Matter: reports of small grey/brown particles found in the primary container identified as brass particulates
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 691,356 containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-03-29
- FDA classified
- 2013-08-02
- Posted by FDA
- 2013-08-14
- Terminated
- 2015-07-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-836-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.