Yeast infection drug recalled. A contamination can cause problems from rash to death
Two lots of a drug used to treat vulvovaginal candidiasis, commonly called vaginal yeast infection, have been recalled nationwide because the manufacturer said there’s a “potential cross contamination with a non- antibacterial beta-lactam drug substance.”
That’s in the FDA-posted recall notice from New Jersey company Scynexis about Brexafemme tablets.
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As for what contaminated Brexafemme can do to users, it “could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life-threatening adverse reaction.”
Brexafemme carries NDC No. 75788-115-04 and are purple, oval tablets with 150 on one side and “SCY” on the other. The recalled lots are No. LF21000008 with expiration date 11/2023 and No. LF22000051 with expiration date 11/2025. They went to drug wholesalers in December 2022.
Sedgwick is handling this recall for Scynexis, reaching out to distributors and wholesalers. If you have recalled Brexafemme as a customer, distributor or wholesaler and Sedgwick hasn’t contacted you about returning the drug, call Sedgwick at 877-551-7154, 8 a.m. to 5 p.m., Eastern time, Monday through Friday.
If you have questions about the contamination leading up to the recall or the safety of other Scynexis drugs, call Scynexis at 201-884-5485.
Any medical problems with the drug should be taken to a medical professional. Then, tell the FDA’s MedWatch program either by filing out a form online or call 1-800-332-1088 to ask for a form you can submit by fax or mail. Only then do you inform Scynexis.
This story was originally published October 1, 2023 at 10:35 AM.