PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 31, 2017 Initiated: April 19, 2017 #D-0866-2017

Product Description

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

Reason for Recall

GMP Deviations; product may not meet cGMP requirements

Details

Recalling Firm
Gentell, Inc
Units Affected
65 gallons
Distribution
Nationwide and Puerto Rico
Location
Bristol, PA

Frequently Asked Questions

What product 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. Recalled by Gentell, Inc. Units affected: 65 gallons.
Why was this product recalled?
GMP Deviations; product may not meet cGMP requirements
Which agency issued this recall?
This recall was issued by the FDA Drug on May 31, 2017. Severity: Moderate. Recall number: D-0866-2017.