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Asclemed USA Inc., dba Enovachem Pharmaceuticals is recalling the product due to labeling that incorrectly states that stoppers do not contain latex.
FDA announced on Dec. 17, 2018 that Asclemed USA Inc., dba Enovachem Pharmaceuticals, is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, including Sodium Chloride, USP, 0.9% manufactured by Fresenius Kabi, because product labeling incorrectly states that stoppers do not contain latex. Patients with a severe allergic reaction to latex may be at risk for an anaphylactic reaction if they use the recalled product.
The recalled products, which were distributed nationwide, are Dyural-40 convenience kits packaged in plastic trays and Dyural-80 convenience kits packaged in plastic trays, containing Sodium Chloride, USP, 0.9% by Fresenius Kabi. More information on recalled lots can be found on FDA’s website.
The company stated in a press release that it has not received any reports of adverse events to date. Adverse events may be reported to FDA through its MedWatch program.