CLASS I Drug recall · Reported 22 Sep 2021 · FDA Enforcement Report
Aminosyn II 15% An Amino Acid Injection, Sulfite-Free recalled
ICU Medical is recalling Aminosyn II 15% An Amino Acid Injection, Sulfite-Free in flexible containers, distributed nationwide in the US. The recall was initiated on 3 Sep 2021 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0805-2021
- FDA event ID
- 88620
- Recalling firm
- ICU Medical, Lake Forest, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 3 Sep 2021
- FDA classified
- 17 Sep 2021
- Reported
- 22 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 3 Sep 2021 | Recall initiated by company | |
| 17 Sep 2021 | Classified by FDA | +14 days |
| 22 Sep 2021 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Which lots are affected?
Lot: 4989094 Exp. 01-APR-2022
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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