Recalls / Class I
Class ID-0969-2015
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, Hospira Inc., Lake Forest, IL, 60045, USA, NDC 0409-7983-02
- Affected lot / code info
- Lot #: 44-002-JT (the lot number may be followed by 01 to 99), Exp 08/01/2016
Why it was recalled
Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in the bag at the additive port area.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 661,128 containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-01-20
- FDA classified
- 2015-04-23
- Posted by FDA
- 2015-04-29
- Terminated
- 2017-01-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0969-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.