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Safety

Recall -- State / Local Press Release

 

FDA posts press releases and other notices of recalls and safety alerts from states as a service to consumers, the media, and other interested parties. FDA is not responsible for the content of these notices.

 

CDC And ADPH Investigate Outbreak At Alabama Hospitals; Products Recalled

 

Contact:
Alabama Department of Public Health
Phone: 334-206-5300
Fax: 334-206-5520
www.adph.org

FOR IMMEDIATE RELEASE - March 29, 2011 - The Alabama Department of Public Health today is announcing 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).

TPN is liquid nutrition fed through an IV using a catheter. Use of contaminated products may lead to bacterial infection of the blood.

ADPH requested assistance from the Centers for Disease Control and Prevention. 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. Affected hospitals are Baptist Princeton, Baptist Shelby, Baptist Prattville, Medical West, Cooper Green Mercy and Select Specialty Hospital in Birmingham.

Meds IV was notified and informed its customers of the possibility of contamination. ADPH has been informed that impacted hospitals immediately stopped using TPN received from this pharmacy and that the pharmacy discontinued all production. On March 24, Meds IV recalled all of its IV compounded products. The U.S. Food and Drug Administration is aware of the voluntary recall. The pharmacy and the hospitals are cooperating with the investigation.

At this time, ADPH is aware of 19 cases in these six hospitals of Serratia marcescens bacteremia related to this outbreak.

ADPH will provide updates as more information becomes available.

Product List

  • Bronch Procedure Kit
  • Bupivacaine Epidural Bag
  • Cardioplegia Solutions
  • Cefazolin 2 gm Syringe
  • Dialysate Solution
  • Fentanyl /Ropivacaine Epidural Bag
  • Fentanyl/ Bupivacaine Epidural Bag
  • Folic Acid 1mg/0.2ml Syringe
  • Glycopyrrolate 0.2mg/ml 1ml in 3ml Syringe
  • Heparin IV Bags
  • Hydromorphone Intravia Bag
  • Hydromorphone PCA Syringe
  • Ketamine Syringe
  • Labetalol syringe
  • Lorazepam 2mg/ml syr
  • Meperidine 10mg/100ml NS(Intravia Bag)
  • Morphine 1mg/ml PCA 100ml Intravia Bag
  • Neostigmine 3mg Syringe
  • Nitroglycerin IV Bag
  • Nitroglycerin Syringe
  • Norepinehrine IV Bag
  • Oxytocin Bags
  • Sodium Chl 23.4% (4meq/ml) 10ml Syr
  • Succinylcholine 20mg/ml 5ml Syringe
  • TPN Solution
  • Vancomycin IV Bag

 

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