FDA recall D-0076-2019
Product Quest Manufacturing LLC · Class II · drug
Product
Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201
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-0076-2019