FDA recall D-0039-2019

Product Quest Manufacturing LLC · Class II · drug

Product

Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube, Distributed by: Harmon Stores, Inc., Union, NJ 07083 USA, UPC 7 27510 00474 7 .

Reason for recall

CGMP Deviations: products manufactured under conditions that could impact its product quality.

Distribution

Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2018-08-03
Report date
2018-10-24
Termination date
2021-03-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Daytona Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0039-2019