Reported Sep 22, 2021 · Terminated

AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake…

ICU Medical Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: ICU Medical Inc · 600 N Field Dr · Lake Forest, IL · 60045-4835

Is this the product you have?

  • 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
Lot codes and dates
  • Lot4989094 Exp. 01-APR-2022
Amount recalled
2,112 Flexible Containers

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 12, 2023 · Data as of Sep 19, 7:24 PM UTC

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