Class I Recall for Compounding Product

Contamination with Burkholderia gladioli has prompted a Class I recall for 2 lots of cherry-flavored SyrSpend SF suspending base by Fagron Inc, according to the May 18, 2022, US Food and Drug Administration (FDA) Enforcement Report. The FDA’s classification of the voluntary recall warns that use of the affected product could cause serious adverse health consequences or death.

“Fagron has received 3 complaints regarding an undesirable smell associated with the product,” the company stated in an April 29, 2022, announcement. “To date, Fagron has not received any reports of adverse events related to the product being recalled.”

The recall affects cherry-flavored SyrSpend SF suspending base in 500-mL bottles (NDC 51552-1123-5) from lot A67185 (Exp. 8/31/24) and 4-L bottles (NDC 51552-1123-9) from lot A67186 (Exp. 8/31/24). The product, which is used in extemporaneous compounding of prescriptions for oral dosing, was distributed throughout the United States and Puerto Rico, as well as in Canada, Columbia, and France.

Fagron initiated the recall March 4, 2022. The FDA designated the recall Class I on May 9, 2022.

“Hospitals, pharmacies, and distributors that possess affected product should quarantine this material and await further instructions from Fagron or Fagron’s recall coordinator,” the company stated. “Please immediately discontinue use or distribution of the recalled product.”