D-461-2014 Class I Terminated
FDA drug recall D-461-2014 was initiated by Hospira Inc. on Aug 30, 2013 and is designated Class I. 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. The recall status is terminated (terminated Aug 21, 2015). Affected quantity: 17,256 containers.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 22, 2014
- Initiation Date
- Aug 30, 2013
- Termination Date
- Aug 21, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,256 containers
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.
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.
Distribution Pattern
Nationwide
Code Information
Lot# 26-138-JT; Exp. 08/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-461-2014
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026