Alabama Hospital Bacterial Infections Linked to Contaminated IV Bags
Federal drug regulators indicate that unsanitary conditions at a specialty pharmacy in Alabama led to a bacterial outbreak in several local hospitals, which may have contributed to the death of at least nine people.
The FDA sent a warning letter to Advanced Specialty Pharmacy, an Alabama pharmacy that was doing business as Meds IV last year when its Total Parentaral Nutrition IV bags were linked to a deadly bacterial outbreak. The letter indicates that the FDA believes that the recalled IV drugs were prepared, packed or held in unsanitary conditions and may have been “contaminated with filth.”
The fact that the drugs were contaminated and sold to the public means they were misbranded as safe, according to the FDA’s letter. Bacteria identical to that which killed and sickened patients was found on faucets inside the production facility.
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In March 2011, Meds IV, an Alabama compounding pharmacy shut their doors and issued a recall for IV bags that contained a liquid nutrient known as Total Parenteral Nutrition (TPN).
The recall was issued after an outbreak of infections involving Serratia marcescens bacteria were identified at six different Alabama hospitals where the IV bags were used. Several hospital infection lawsuits were filed as a result.
The Alabama hospitals known to have received the tainted IV bags include Baptist Princeton, Baptist Shelby, Baptist Prattville, Medical West, Cooper Green Mercy and Select Specialty Hospital in Birmingham.
The FDA acknowledges that the company has surrendered its pharmacy license as a result of the incident. If the company were ever attempt to reopen, it would have to tell the FDA at least 15 days ahead of time, explaining how it would prevent a similar outbreak.
Serratia marcescens is a waterborne bacteria that can cause fever, respiratory problems and shock. The Alabama Department of Public Health investigators found bacteria on a faucet and medical equipment at the Meds IV lab. The company has since decided to cease operations and officials with the Centers for Disease Control and Prevention (CDC) have indicated that it is unlikely the business will reopen.
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