Recalls / Class I
Class ID-922-2013
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, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23
- Affected lot / code info
- Lot Number 05-201-JT, Expiration Date 1MAY2013
Why it was recalled
Presence of Particulate Matter; product may contain fibrous material
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 264,432 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2012-08-31
- FDA classified
- 2013-08-26
- Posted by FDA
- 2013-09-04
- Terminated
- 2015-05-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-922-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.