FDA-Drug2021-09-22Class I

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

ICU Medical Inc
Hazard

Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.

Sold states
Distributed Nationwide in the USA
Affected count
2,112 Flexible Containers
Manufactured in
600 N Field Dr, N/A, Lake Forest, IL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0805-2021

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