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.
The affected lots for SyrSpend SF are:
The affected lots for SyrSpend SF Grape lots are:
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.