FDA Recall D-461-2014
Hospira Inc. · Lake Forest, IL
Class I — life-threatening Terminated 721 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.
Reason for recall
Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
Recall record
- Recall number
D-461-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide
- Recall initiated
- 2013-08-30
- Classified by FDA Center
- 2014-01-13
- FDA published
- 2014-01-22
- Terminated
- 2015-08-21
- Recalling firm
- Hospira Inc.
- Firm location
- Lake Forest, IL