Recalls

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.

READ MORE: Florida company recalls medicine for microbial contamination

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.

The label for Brexafemme
The label for Brexafemme National Library of Medicine

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.

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David J. Neal
Miami Herald
Since 1989, David J. Neal’s domain at the Miami Herald has expanded to include writing about Panthers (NHL and FIU), Dolphins, old school animation, food safety, fraud, naughty lawyers, bad doctors and all manner of breaking news. He drinks coladas whole. He does not work Indianapolis 500 Race Day.
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