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Flavoring, Suspending Agent Used in Drug Compounding Contaminated with Yeast


On February 10, 2016, the FDA alerted compounding pharmacies about a voluntary recall of certain lots of SyrSpend SF and SyrSpend SF Grape suspending agents used in compounding of various oral liquid drug products, due to the presence of yeast (Candida galli). The FDA is not aware of adverse events reports with patients who may have used the suspending agents.

 

If an immunocompromised patient or a child with an immature immune system ingests the contaminated product, there is a potential the patient will get an infection for which systemic antimicrobial therapy would be necessary.

 

The FDA recommends that compounders not use the referenced lots of contaminated Syrspend SF and Syrspend SF Grape in compounding drug products for patients. Compounding pharmacies who have received the referenced lots of Syrspend SF and Syrspend SF Grape flavor should immediately discontinue use, quarantine the products, and return the products to Fagron, Inc.

 

See the CDER Alert

 

See the FDA Safety Alert

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication 

 

 

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