FDAClass ISeptember 22, 2021

AMINOSYN II 15% An Amino Acid Injection recall: Particulate Matter

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

Why was AMINOSYN II 15% An Amino Acid Injection recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 4989094 Exp. 01-APR-2022

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
Recalling firm
ICU Medical Inc
Quantity
2,112 Flexible Containers
Distribution
Distributed Nationwide in the USA
Recall date
September 22, 2021
Classification
Class I
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls