Drug 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
D-0805-2021
Product summary
- Firm
- ICU Medical Inc
- Event
- Event 88620
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2,112 Flexible Containers
- Official record key
drug-enforcement:D-0805-2021
Official wording
Reason: Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Code information: Lot: 4989094 Exp. 01-APR-2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter