Blaine Labs Inc: TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio,
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- 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 / hazard
- CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Nationwide in the USA
- Recall initiated
- 2026-04-08
- Code info
- Lot #BL3411R, Exp 6/8/2027
- Product quantity
- 144 bottles
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Santa Fe Springs
- State
- CA
- Country
- United States
- Event id
- 98731
Free daily digest + "My products" watchlist