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Blaine Labs Inc: TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante F

DrugsSource: FDA (drug) · Date: 2026-07-08

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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
TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01.
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
Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027.
Product quantity
22,143 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Santa Fe Springs
State
CA
Country
United States
Event id
98731
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