D-0694-2026 Class II Ongoing
FDA drug recall D-0694-2026 was initiated by Blaine Labs Inc on April 8, 2026 and is designated Class II. Reason for recall: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry The recall status is ongoing. Affected quantity: 144 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 8, 2026
- Initiation Date
- April 8, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 144 bottles
Product Description
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.
Reason for Recall
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Distribution Pattern
Nationwide in the USA
Code Information
Lot #BL3411R, Exp 6/8/2027