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

FDA recall notice · announced September 22, 2021 · Icu Medical

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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

Reason for recall

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

Notes

Distribution: Distributed Nationwide in the USA
Lot/code information: Lot: 4989094 Exp. 01-APR-2022
Quantity: 2,112 Flexible Containers
Status: Terminated
Products in this recall event:
- 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 (D-0805-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.