FDA recall D-0033-2019

Product Quest Manufacturing LLC · Class II · drug

Product

CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 29380 5 Product #459367.

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-0033-2019