Monday, September 2, 2013

Hospira Issues A Voluntary Nationwide Recall Of One Lot Of Aminosyn II 10 percent, Sulfite-Free, Due To Foreign Particulate Matter

You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

This information has recently been updated and is now available.

 

08/30/2013 08:24 PM EDT

Hospira, Inc. announced today it is initiating a voluntary nationwide user-level recall of one lot of Aminosyn II 10 percent, Sulfite-Free, 500mL, NDC 0409-4164-03 Lot 26-138-JT. This action is due to one confirmed customer report where an unknown foreign particle was included in the injection port and in contact with product. The foreign particle was confirmed by Hospira as human hair. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. This recall is being conducted as a precautionary measure.

. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.


This email was sent to filter@clubhouseb.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery

No comments:

Post a Comment