Certain Grape Suspending Agents Recalled
Certain lots of SyrSpend SF and SyrSpend SF Grape suspending agents recalled due to the presence of yeast.
The FDA is warning compounding pharmacies about certain lots of SyrSpend SF and SyrSpend SF Grape suspending agents due to the presence of yeast.
Fagron is voluntarily recalling certain lots of the agents used in the compounding of various oral liquid drug products.
The SyrSpend SF lots affected by the recall are: 15I21-U01-026920, 15J26-U05-027457, 15J26-U05-027473, 15I21-U01-027370, and 15J19-U05-027406.
The 3 SyrSpend SF Grape lots affected are: 15G29-U03-025975, 15A05-U03-022765, and 15A05-U06-023277.
“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 stated in its warning to compounding pharmacies.
However, the FDA has not been notified of any adverse events related to this issue thus far.
Compounders should not use these products, and if a pharmacy has already started using the referenced lots, the FDA encourages immediate discontinuation.
The items may be returned to Fagron, and adverse effects may be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.