Status
Terminated
Drug Enforcement D-461-2014
Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
Classification
Class I
Report Date
January 22, 2014
Termination Date
August 21, 2015
Product Information
- Product description
- 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.
- Product quantity
- 17,256 containers
- Reason for recall
- Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as a human hair, visible in the injection port and primary container.
- Recall initiation reason
- —
- Initial firm notification
- Press Release
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Hospira Inc.
- Address
-
275 N Field Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-461-2014
- Event ID
- 66147
- Recall initiation date
- August 30, 2013
- Center classification date
- January 13, 2014
- Code info
- Lot# 26-138-JT; Exp. 08/14
- More code info
- —