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Safety Report: Fagron SyrSpend SF 500mL and 4L - recalled due to Burkholderia gladioli, USA

2 years ago •source fda.gov

Recall notice

Fagron SyrSpend SF 500mL and 4L - recalled due to Burkholderia gladioli photo #1

United States

St. Paul, Minnesota, 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.

Affected products:
Lot: A67185
Item number: 805359
Size: 500 mL
NDC number: 51552-1123-5
Expiration date: 08/31/2024

Lot: A67186
Item number: 802496
Size: 4 L
NDC number:51551-1123-9
Expiration date: 08/31/2024

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.

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

Company name: Fagron Inc.
Brand name: Fagron
Product recalled: SyrSpend SF 500mL and 4L
Reason of the recall: Potential contamination with Burkholderia gladioli
FDA Recall date: May 02, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fagron-inc-issues-voluntary-nationwide-recall-syrspend-sf-cherry-due-microbial-contamination

#drugs #us #pita #ro-tel

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