Date Sent: 08/10/2016 05:04 PM EDT
Sender: Michigan Health Alert Network
Subject: Update #3: Mulitstate Burkholderia cepacia investigation-2016
FDA Update: August 10, 2016
FDA released an updated statement including a voluntary recall of all of liquid products manufactured by PharmaTech and distributed by: Rugby, Major, Bayshore, Metron, Centurion, and Virtus.
Instructions and a product list are included in the announcements, which can be read at http://www.fda.gov/Drugs/DrugSafety/ucm511527.htm and http://www.fda.gov/Safety/Recalls/ucm515610.htm.
Consumers, pharmacies, and health care facilities that have product which is being recalled should stop using and dispensing them immediately. Using these products in a patient whose immune system is compromised could result in infections, which may be life-threatening.
This issue remains under investigation. In addition to the above recall of all liquid products manufactured by PharmaTech, both FDA and CDC continue to recommend that clinicians and patients not use any brand of liquid docusate sodium product as a stool softener or for any other medical purpose.
As of August 10, CDC has confirmed 60 Burkholderia cepacia cases from 8 states.
An update will be posted to http://www.cdc.gov/hai/outbreaks/b-cepacia/index.html in approximately one week.
Please direct questions to firstname.lastname@example.org. Members of the media should contact the CDC Media Office at email@example.com.
To report clusters, please contact the MDHHS Communicable Disease Division's SHARP Unit via phone (517-335-8165) or email (firstname.lastname@example.org or email@example.com).
Thank you for your time and attention to this important matter.