Blaine Labs recalls TERPENICOL Antifungal Solution due to discontinued stability testing, risking product degradation. Affected units have specific lot numbers and expiration dates.
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Blaine Labs is recalling their TERPENICOL Antifungal Solution because they stopped required stability testing for products still within their expiration dates. This could lead to the product degrading over time, potentially affecting its effectiveness.
The product was manufactured without completing necessary stability testing, which means its effectiveness and safety could decrease over time. This is a regulatory issue that does not pose an immediate risk of injury but could affect the product's intended use.
Users of TERPENICOL Antifungal Solution, particularly those with the specific lot numbers and expiration dates listed in the recall notice. People using the product for medical purposes may be at higher risk if the solution degrades.
Check the product label for the lot numbers BL3411R (expiring 06/08/2027), BL3468 (expiring 03/07/2027), or BL3535 (expiring 09/25/2027). The product is a 1.0 fl oz antifungal solution from Blaine Labs.
Look for lot numbers BL3411R, BL3468, or BL3535 on the product label.
The recall is due to discontinued stability testing, which could affect the product's effectiveness over time. It does not pose an immediate risk of injury.
Check the product label for lot numbers BL3411R (expiring 06/08/2027), BL3468 (expiring 03/07/2027), or BL3535 (expiring 09/25/2027).
The recall does not specify a remedy, so contact Blaine Labs for guidance on next steps.
We’ve drafted a message you can send Blaine Labs to request your refund or repair — edit it as you like.
Subject: Recall D-0697-2026 — Blaine Labs Blaine Labs Hello, I own a Blaine Labs that is covered by recall D-0697-2026 from Blaine Labs. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
