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

FDA recall notice · announced May 31, 2017 · Gentell

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

GMP Deviations; product may not meet cGMP requirements

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Product Code GEN-23240
Quantity: 65 gallons
Status: Terminated
Products in this recall event:
- 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 (D-0866-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.