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Class I: serious health riskTerminated

ICU Medical AMINOSYN II 15% An Amino Acid Injection Recall

AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers,…

ICU Medical Inc · Lake Forest, IL

Risk level
Class I
Reported by FDA
Sep 22, 2021
Recall ID
D-0805-2021
Check your lot numberHow we source this data

Summary

ICU Medical recalled AMINOSYN II 15% An Amino Acid Injection starting Sep 3, 2021. The FDA classified it as Class I (serious health risk) and published enforcement report D-0805-2021 on Sep 22, 2021. Reason: Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples. Status: Terminated.

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.

Product description

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 numbers, UPCs & expiration codes

Lot: 4989094 Exp. 01-APR-2022

Where it was sold

Distributed Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0805-2021
Classification
Class I
Status
Terminated
Recall initiated
Sep 3, 2021
FDA report date
Sep 22, 2021
Quantity
2,112 Flexible Containers
Recall type
Voluntary: Firm initiated
Recalling firm
ICU Medical Inc

Original FDA data

Every field from FDA enforcement report D-0805-2021, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
88620
Address
600 N Field Dr
Code information
Lot: 4989094 Exp. 01-APR-2022
Postal code
60045-4835
Report date
Sep 22, 2021
Product type
Drugs
Recall number
D-0805-2021
Classification
Class I
Recalling firm
ICU Medical Inc
Product quantity
2,112 Flexible Containers
Termination date
Jul 12, 2023
Reason for recall
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Distributed Nationwide in the USA
Recall initiation date
Sep 3, 2021
Initial firm notification
Press Release
Center classification date
Sep 17, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0805-2021, published Sep 22, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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