Class II Recall

Blaine Labs Inc

Product
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
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Classification
Class II
Status
Ongoing
Lot
Lot #BL3411R, Exp 6/8/2027
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.