TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%): recall status
Notice names this product. Blaine Labs’s TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%) is named in FDA Class II recall D-0694-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies.Agency-reported hazard: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry Identifying details: Lot #BL3411R, Exp 6/8/2027. Units affected: 144 bottles. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named
TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%)
Company / brand
Blaine Labs
Lot / serial / date codes
Lot #BL3411R, Exp 6/8/2027
Distribution
Nationwide in the USA
Agency product description and boundaries
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.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.