An urgent recall of a one-time-dose treatment for vaginal yeast infection has been issued after the discovery of a dangerous contaminant in the drug. Brexafemme® (ibrexafungerp) tablets are manufactured by Scynexis, Inc. During a routine inspection, the presence of a non-antibacterial β-lactam drug substance was noted. When ingested, the substance can cause severe reactions, including death. As of the writing of this notice, no adverse events have yet been reported.
SUMMARY
Date of Recall:
Announced: September 27, 2023
Public Notification: September 28, 2023
Name(s) of Drug:
Brexafemme (ibrexafungerp)
Company Name:
Scynexis, Inc.
Drug Indication:
Fungal Infection
Vaginal Yeast Infection
Vulvovaginal Candidiasis
Recurrent Vulvovaginal Candidiasis
Product Description
The prescription medication is distributed by pharmacies nationwide. The pills are oval-shaped and purple. Each bears the number 150 on one side and the letters SCY on the other. The pills are distributed in blister packs that are contained within a box containing blue, yellow, green, and pink accents.
Reason for Recall
Scynexis, Inc. noted contamination with a non-antibacterial β-lactam during the manufacturing process. They are issuing the recall out of an abundance of caution, though no adverse events have yet been reported.
Impacts
Consumers who receive and consume a contaminated batch of the medication may experience:
- Edema (swelling)
- Dermatitis (rash)
- Urticaria (hives)
- Anaphylaxis (allergic reaction leading to inability to breathe, vomiting, nausea, weak/rapid pulse, low blood pressure)
Lot Information
Consumers should locate the box in which the medication comes to compare NDC, lot numbers, and expiration dates with the chart below. If you find your NDC number, lot number, and expiration date on the chart below, your medication is affected by the recall, and you will need to take additional steps to ensure that your health is not affected and to take part in recall procedures.
Product Description |
NDC |
Lot Number |
Expiration Date |
| BREXAFEMME® |
75788-115-04 |
LF21000008 |
11/2023 |
| BREXAFEMME® |
75788-115-04 |
LF22000051 |
11/2025 |
Have you found that your medication is part of the recall? Here’s what you should do:
Consumers
- Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any changes in your symptoms.
- Continue to monitor your health for any adverse symptoms. Notify your physician if any concerns are noted.
- Consumers may contact Sedgwick at 1-877-551-7154. They are available Mon-Fri from 8:00 a.m. to 5:00 p.m. (EST). You can also contact them via email at media@scynexis.com.
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock affected by the recall immediately.
- Contact Sedgwick at 1-877-551-7154, or you can utilize media@scynexis.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock affected by the recall immediately.
- Contact Sedgwick at 1-877-551-7154, or you can utilize media@scynexis.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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