FDA recall D-0041-2019

Product Quest Manufacturing LLC · Class II · drug

Product

meijer, Saline Nasal Spray, Nasal Moisturizing Spray, packaged as a) 1.5 FL OZ (44 mL) UPC 7 08820 74428 8; b) 3FL OZ (88 mL) UPC 7 08820 74430 1, Dist. By Meijer Distribution, Inc., Grand Rapids, MI 49544 .

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-0041-2019