Recalls / Class I
Class ID-0805-2021
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 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17
- Affected lot / code info
- Lot: 4989094 Exp. 01-APR-2022
Why it was recalled
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Recalling firm
- Firm
- ICU Medical Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 600 N Field Dr, N/A, Lake Forest, Illinois 60045-4835
Distribution
- Quantity
- 2,112 Flexible Containers
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-09-03
- FDA classified
- 2021-09-17
- Posted by FDA
- 2021-09-22
- Terminated
- 2023-07-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0805-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.