FDA recall D-0114-2019

Product

SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0001-1 and Tester NDC 6196-1001-1

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-0114-2019