SleepEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. ...
FDA Recall #D-0114-2019 — Class II — October 9, 2018
Product Description
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.
Recalling Firm
Sprayology — Gaithersburg, MD
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
5,393 bottles
Distribution
Distributed Nationwide in the USA
Code Information
All lots within expiry
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated