Drug & medication recalls Moderate risk

Shield and Protect Moisture Barrier Cream recalled over manufacturing violations

Recall date
April 19, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Gentell, Inc recalls Shield and Protect Moisture Barrier Cream, 1.1% Clotrimazole, Net Weight 4 oz - 115 g Anti-Fungal, Gentell, Inc., Brist…
Recall number
D-0866-2017
FDA classification
Class II
Brand / firm
Gentell, Inc
Sold / distributed
Nationwide and Puerto Rico

Why it was recalled

GMP Deviations; product may not meet cGMP requirements

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

Get recall alerts

Free email alert whenever Gentell, Inc has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Gentell, Inc