FDA recall D-0866-2017

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

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2017-04-19

Report date

2017-05-31

Termination date

2018-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bristol, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0866-2017