FDA recall D-0077-2019

Product

Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687901 w/ Silo

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-0077-2019