Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Shield and Protect Moisture Barrier Cream Recalled by Gentell, Inc Due to GMP Deviations; product may not meet cGMP requirements

Date: April 19, 2017
Company: Gentell, Inc
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Gentell, Inc directly.

Affected Products

Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Bristol, PA NDC 61554-232-40

Quantity: 65 gallons

Why Was This Recalled?

GMP Deviations; product may not meet cGMP requirements

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Gentell, Inc

Gentell, Inc has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report