Drug product
Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4164-03, UPC (01) 0 030409 416403 8.
D-461-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 66147
- Status
- Terminated
- Classification
- Class I
- Quantity
- 17,256 containers
- Official record key
drug-enforcement:D-461-2014
Official wording
Reason: Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
Code information: Lot# 26-138-JT; Exp. 08/14
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter