FDA recalls BREXAFEMME tablets due to cross-contamination with ezetimibe
The FDA is recalling BREXAFEMME antifungal tablets due to potential cross-contamination with ezetimibe during manufacturing, with two lot numbers distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification requires a minimum severity score of 4 per recall criteria. Although no illnesses or deaths have been reported, the agency's classification reflects potential for serious adverse health consequences from the unintended drug substance.
Plain-English summary
BREXAFEMME (Ibrexafungerp) 150 mg tablets manufactured by Scynexis, Inc. are being recalled. The recall addresses potential cross-contamination of the drug substance with ezetimibe, an unrelated medication, during manufacturing.
The affected product is distributed in 4-count cartons under two lot numbers: Lot LF21000008 (expiring 11/30/2023) and Lot LF22000051 (expiring 11/30/2025). A total of 17,376 units were distributed nationwide in the United States.
This is an FDA Class I recall, reflecting the agency's determination that the contamination poses a serious health risk. The potential presence of an unintended substance in patients' medication could result in unexpected health effects.
The recalled product
- Product
- BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04
- Manufacturer
- Scynexis, Inc.
- Category
- Drug — Antifungal Medication
- Affected units
- 17,376
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot# LF21000008
- Exp. 11/30/2023 Lot# LF22000051
- Exp. 11/30/2025
Distribution
Distributed nationwide across the United States.
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