FDA recall D-0118-2019

Sprayology · Class II · drug

Product

Snore Soother, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0024-1

Reason for recall

CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.

Distribution

Distributed Nationwide in the USA

Key facts

Status
Terminated
Initiation date
2018-10-09
Report date
2018-11-07
Termination date
2019-04-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gaithersburg, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0118-2019