Thursday, May 22, 2014

Voluntary Nationwide and Canada Recall of NaturaLyte® Liquid Bicarbonate Concentrate Due to Potential Health Risk

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.

 

05/22/2014 12:39 PM EDT

Fresenius Medical Care North America (FMCNA) announced today that its voluntary recall of 56 lots of NaturaLyte® Liquid Bicarbonate Concentrate, 6.4 liters (intended for use in hemodialysis machines) from distribution has been classified as a Class 1 Recall. The affected lots were produced in its Montreal, Canada facility and are being recalled because they may develop higher bacteria levels than is allowed by the company’s internal specification during their shelf life.

. 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