TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01.

Recall Number: D-0694-2026

Firm: Blaine Labs Inc

Classification: Class II

Status: Ongoing

Report Date: 20260708

Initiation Date: 20260408

Termination Date:

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01.