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Aminosyn II with Dextrose FDA Alerts

The FDA Alert(s) below may be specifically about Aminosyn II with Dextrose or relate to a group or class of drugs which include Aminosyn II with Dextrose (parenteral nutrition solution).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for parenteral nutrition solution

Meds IV Pharmacy, IV Compounded Products Recall: Outbreak of Serratia Marcescens Bacteremia in Alabama Hospitals

Mar 30, 2011

Audience: Risk Manager, Pharmacy

ISSUE: The Alabama Department of Public Health announced an ongoing investigation of an outbreak of Serratia marcescens bacteremia in six Alabama hospitals. On March 16, ADPH was notified that an outbreak had occurred in two of these hospitals among patients receiving TPN (total parenteral nutrition). ADPH is aware of 19 cases in these six hospitals of Serratia marcescens bacteremia related to this outbreak.

BACKGROUND: CDC's initial investigation identified TPN produced by a single pharmacy, Meds IV, as a potential common source and has determined that these hospitals received TPN from this pharmacy. At this time, Meds IV recalled all of its IV compounded products.

RECOMMENDATION: Remove the recalled products from Meds IV Pharmacy from shelves. Refer to the Press Release for a complete list of affected products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[03/29/2011 - State Press Release - Alabama Department of Public Health]