D-0805-2021 Class I Terminated
FDA drug recall D-0805-2021 was initiated by ICU Medical Inc on September 3, 2021 and is designated Class I. Reason for recall: Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples. The recall status is terminated (terminated July 12, 2023). Affected quantity: 2,112 Flexible Containers.
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