Medicine recalls
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| The United States: Fagron Inc. issues voluntary nationwide recall of SyrSpend SF Cherry due to microbial contamination |
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The US Food and Drug Administration (FDA) announces that Fagron Inc. is voluntarily recalling two lots of SyrSpend SF Cherry (lot number: A67185, A67186) 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fagron-inc-issues-voluntary-nationwide-recall-syrspend-sf-cherry-due-microbial-contamination
In Hong Kong, the above product is not a registered pharmaceutical product. There is also no registered pharmaceutical product manufactured by Fagron Inc.
Ends/Tuesday, May 3, 2022
Issued at HKT 14:00
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