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U.S. Department of Health and Human Services

Drugs

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FDA releases laboratory results of Specialty Compounding recalled products confirming contamination

 

[11-15-2013] The U.S. Food and Drug Administration investigators conducted an inspection of Specialty Compounding’s sterile drug compounding and manufacturing facility in Cedar Park, Texas. This inspection was conducted following 15 reports from two hospitals in Texas of bacterial infections potentially associated with compounded products. Following these reports, Specialty Compounding voluntarily recalled all products for sterile use.
 
The FDA inspected Specialty Compounding from August 13 to September 13, 2013, and collected samples of the company’s compounded products at the firm and at various health care facilities. Analysis of these samples identified contaminants in recalled products:   
 

MedicationLot NumberContamination
Calcium Gluconate 10%
05142013M14
Non-viable mold-like hyphae
Calcium Gluconate 2GM/100ML Sodium Chloride 0.9% Injectable
07092013M16
Kocuria kristinae 
Kocuria varians
Gardnerella vaginalis
Streptococcus pluranimalium 
Streptococcus thoraltensis

 
Based on our inspectional findings and the sample results, we do not believe Specialty Compounding should perform any sterile drug production at this time.