FDA recall D-0291-2019

Product

SHEER DesenZ Desensitizing Treatment, Rx Only, Potassium Nitrate 12mg per film. CAO GROUP, INC, 4628 West Skyhawk Drive West Jordan, UT 84084. UPC: 8 72320 00072 1 NDC 1406000304

Reason for recall

cGMP violations noted during the firm's most recent inspection.

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2018-11-16

Report date

2018-12-19

Termination date

2020-02-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Jordan, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0291-2019