Scynexis is recalling 2 lots of Brexafemme^® (ibrexafungerp tablets), an oral antifungal agent used to treat vulvovaginal candidiasis (VVC) and reduce the incidence of recurrent VVC.

The Company announced the move in a filing after it was discovered that during the manufacturing process, there may have been possible cross contamination with a non-antibacterial beta-lactam drug substance. According to the Food and Drug Administration (FDA), non-antibacterial compounds containing a beta-lactam ring could have similar sensitizing and allergenic properties as beta-lactam antibacterial drugs and may pose a significant health risk to patients. 

Though it is not known whether any ibrexafungerp has been contaminated, given the potential risk, Scynexis has decided to recall the following lots:

• Lot# LF21000008 (expiration date 11/2023)
• Lot# LF22000051 (expiration date 11/2025)

The affected product was distributed nationwide beginning in December 2022. At this time, there have been no reports of adverse events linked to this issue. Adverse events and quality problems should be reported to the FDA’s MedWatch program.

In addition to the recall, the Company has decided to place a temporary hold on clinical studies involving ibrexafungerp. This includes the phase 3 MARIO study (ClinicalTrials.gov Identifier: NCT05178862), which is investigating ibrexafungerp as part of a treatment regimen for invasive candidiasis.

Family Dollar has initiated a recall of several over-the-counter (OTC) products and medical devices that were stored outside of labeled temperature requirements. These products were shipped to stores between June 1, 2023 and September 21, 2023 and were sold through October 4, 2023.

The recall includes cough and cold products, pain relievers, and medications to relieve constipation and diarrhea, among others. The full list of affected products can be found here. The items were sold in AL, AR, AZ, CA, CO, FL, GA, ID, KS, LA, MS, MT, ND, NE, NM, NV, OK, OR, SD, TX, UT, WA, and WY.

At this time, there have been no reports of adverse events associated with the recalled products. According to the Company, the recall is being conducted out of an abundance of caution. 

Individuals with questions related to this recall can contact Family Dollar customer service at 844-636-7687. Adverse events and quality issues should be reported to the Food and Drug Administration’s MedWatch program.

The Food and Drug Administration (FDA) has approved Likmez, a ready-to-use liquid suspension formulation of metronidazole.

Likmez oral suspension is supplied in a 200mL bottle containing 500mg/5mL of metronidazole in a strawberry peppermint flavor. The product does not require refrigeration.

Likmez is indicated for the treatment of:

• Symptomatic trichomoniasis caused by Trichomonas vaginalis in adult females and males when the diagnosis is confirmed.
• Asymptomatic trichomoniasis caused by Trichomonas vaginalis in adult females when the organism is associated with endocervicitis, cervicitis, or cervical erosion.
• Acute intestinal amebiasis (amoebic dysentery) and amebic liver abscess in adults and pediatric patients.
• Serious infections caused by susceptible anaerobic bacteria in adults.

“Difficulty swallowing tablets and capsules should not be a barrier to accessing appropriate antibiotic therapy,” said Don Cilla, PharmD, MBA, Appili’s President and CEO. “Likmez provides a convenient alternative for patients who have difficulty taking solid oral medicines.”