FDAClass IIMay 31, 2017

Shield and Protect Moisture Barrier Cream recall: CGMP Deviations

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

Why was Shield and Protect Moisture Barrier Cream recalled?

GMP Deviations; product may not meet cGMP requirements

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code GEN-23240

Product
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
Recalling firm
Gentell, Inc
Quantity
65 gallons
Distribution
Nationwide and Puerto Rico
Recall date
May 31, 2017
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls