Fagron Inc SyrSpend SF Cherry
Fagron Inc SyrSpend SF Cherry

Fagron Inc. (“Fagron”) is voluntarily recalling two lots of SyrSpend SF Cherry to the hospital, pharmacy, and distributor level out of an abundance of caution. The affected lots are potentially contaminated with Burkholderia gladioli.

Burkholderia gladioli is an opportunistic pathogen most commonly affecting patients with respiratory disease. Patients with compromised immune systems such as those with Cystic Fibrosis are at higher risk. Burkholderia gladioli also can cause complications after transplants. Exposure to contaminated product could lead to adverse events, which could be severe for at-risk individuals. Fagron has received three complaints regarding an undesirable smell associated with the product. To date, Fagron has not received any reports of adverse events related to the product being recalled.

Fagron sells this product for the extemporaneous compounding of prescriptions for oral dosing. The affected lots with expiration dates are listed below.

LotItem numberSizeNDC numberExpiration date
A67185805359500 mL51552-1123-508/31/2024
A671868024964 L51551-1123-908/31/2024

Fagron has already notified its distributors and customers by phone, e-mail, and/or letter and is arranging for return of all recalled products. Hospitals, pharmacies, and distributors that possess affected product should quarantine this material and await further instructions from Fagron or Fagron’s recall coordinator. Please immediately discontinue use or distribution of the recalled product. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Fagron has contracted with Sedgwick to facilitate this recall. Consumers with questions regarding this recall may contact Fagron Customer Service at 1-800-423-6967 from 9:00a.m. to 5:00p.m. Central Daylight Time, Monday through Friday, or by email at customer.service@fagron.us. Questions specific to the return of product should be directed to Sedgwick at 1-877-650-8362 or by email at fagron4043@sedgwick.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Original recall and updates at FDA

Leave a Reply

Your email address will not be published.

You cannot copy content of this page