Contaminated Suspending Agents Used for Compounding Recalled

Currently, the FDA has not received any adverse events reports from patients
Currently, the FDA has not received any adverse events reports from patients

The Food and Drug Administration (FDA) informed that Fagron, Inc. is voluntarily recalling certain lots of SyrSpend SF and SyrSpend SF Grape suspending agents used in various oral liquid compounded products due to the presence of Candida galli, a type of yeast.

If a child with an immature immune system or an immunocompromised patient consumes the contaminated product, the patient may potentially develop an infection that would require systemic antimicrobials. 

RELATED: Study Reveals Most Common Reasons for FDA Recalls

The affected lots for SyrSpend SF are:

  • 15I21-U01-026920
  • 15J26-U05-027457
  • 15J26-U05-027473
  • 15I21-U01-027370
  • 15J19-U05-027406
The affected lots for SyrSpend SF Grape lots are:
  • 15G29-U03-025975
  • 15A05-U03-022765
  • 15A05-U06-023277

The FDA recommends compounders to not use the affected lots listed below when compounding drug products for patients. Pharmacies in possession of the recalled products should discontinue use, quarantine the products, and arrange for return to Fagron, Inc.

Currently, the FDA has not received any adverse events reports with patients who may have used the suspending agents.

For more information visit FDA.gov.

Loading links....