Recalls / Class I
Class ID-461-2014
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
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.
- Affected lot / code info
- Lot# 26-138-JT; Exp. 08/14
Why it was recalled
Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
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
- 17,256 containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-08-30
- FDA classified
- 2014-01-13
- Posted by FDA
- 2014-01-22
- Terminated
- 2015-08-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-461-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.