Recalls / Class I
Class ID-0976-2015
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, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.
- Affected lot / code info
- Lot # 45-110-C6; Exp 03/1/16
Why it was recalled
Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 9,912 VisIV flex containers
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2015-03-05
- FDA classified
- 2015-05-04
- Posted by FDA
- 2015-05-13
- Terminated
- 2016-06-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0976-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.