FDA MedWatch - SyrSpend SF Cherry by Fagron

Recall - Due to Microbial Contamination

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC:  SyrSpend SF Cherry by Fagron: Recall - Due to Microbial Contamination AUDIENCE: Health Professional, Pharmacy, Patient  ISSUE: Fagron is recalling two lots, A67185 and A67186, of SyrSpend SF Cherry because 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. For more information about this recall, click on the red button Read Recall below. BACKGROUND: Fagron sells this product for the extemporaneous compounding of prescriptions for oral dosing. RECOMMENDATIONS:  Hospitals, pharmacies, and distributors that possess affected product should quarantine this material and await further instructions. 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. Consumers with questions regarding this recall may contact Fagron Customer Service.     Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178. Follow us on Twitter at @FDAMedWatch

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