FDA recall D-0051-2019

Product Quest Manufacturing LLC · Class II · drug

Product

Rite Aid Pharmacy, nasal relief NO DRIP PUMP SPRAY nasal spray, (oxymetazoline hydrochloride 0.05%), 12 Hour, 1 FL OZ (30 mL) bottle, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, UPC 0 11822 31412 1.

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-0051-2019