D-0805-2021 Class I Terminated

Recalled by ICU Medical Inc — Lake Forest, IL

Recall Details

Product Type
Drugs
Report Date
September 22, 2021
Initiation Date
September 3, 2021
Termination Date
July 12, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,112 Flexible Containers

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

Reason for Recall

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

Distribution Pattern

Distributed Nationwide in the USA

Code Information

Lot: 4989094 Exp. 01-APR-2022