TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01

Recall Number: D-0697-2026

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

TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01