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.
Source: FDA
