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Author Topic: FDA Recall - Specialty Compounding All States Affected Except NC  (Read 937 times)
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MuffyBee
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« on: August 11, 2013, 07:37:54 PM »

http://www.greenfieldreporter.com/view/story/a6e92bb2087949ad9d88a0a02837085d/US--FDA-Specialty-Compounding-Recall
FDA announces recall of sterile medications produced by Specialty Compounding in Texas
August 11, 2013

NEW YORK The FDA on Sunday announced a recall of all products produced and distributed for sterile use by Specialty Compounding LLC because of concerns about bacterial infections

The Cedar Park, Texas, company is recalling all lots of its unexpired sterile compounded medications sold since May 9, including all strengths and dosage forms.

The company announced the recall late Friday.

The agency said the recall follows reports of bacterial infections affecting 15 patients at two Texas hospitals, Corpus Christi Medical Center Doctors Regional and Corpus Christi Medical Center Bay Area. All of the cases involved treatment that included IV infusions of calcium gluconate from Specialty Compounding.

There is a potential association between the infections and the medication, the notice states. It adds that if there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.


The company said the recalled products were sent directly to patients nationwide, with the exception of North Carolina. They were also distributed directly to hospitals and physician offices in Texas.

Specialty Compounding, a subsidiary of Peoples Pharmacy Inc., is notifying its customers by telephone, fax, electronic mail and/or regular mail of this recall. Users or recipients of these products should immediately discontinue use and return the products to Specialty Compounding.

More details are available by calling Specialty Compounding at 512-219-0724, Monday through Friday, between 10:00 a.m. and 5:00 p.m. Central time.
More information...
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MuffyBee
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« Reply #1 on: August 14, 2013, 10:50:18 PM »

http://www.kxan.com/dpp/news/local/austin/patients-who-received-recalled-drug-die
Patients who received recalled drug die
Currently no link to recalled drug

August 14, 2013

EL PASO, Texas (AP) - Texas health officials say no link has been found between a compounded drug and two patients who developed infections after receiving it before its recall.

The Federal Drug Administration recalled all products produced by Specialty Compounding of Cedar Park, Texas, after reports of bacterial infections affecting 17 patients at two Corpus Christi hospitals.

A spokesman for the Texas Department of State Health Services says the two patients who have died had been administered the calcium gluconate. Spokesman Chris Van Deusen said, however, that the cause of death is not yet known and no link to the medication has been established.

The Food and Drug Administration is closely watching compounding pharmacies right now.  The agency's target is pharmacies making big batches of drugs and shipping them to doctors often across state lines.
 
The company has said the recalled products were sent directly to patients nationwide, except in North Carolina. They were also distributed to Texas hospitals and physicians.
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  " Everyone is entitled to his own opinion, but not his own facts."  - Daniel Moynihan
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