PlainRecalls
FDA Drug Moderate Class II Terminated

DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0005-1

Reported: November 7, 2018 Initiated: October 9, 2018 #D-0113-2019

Product Description

DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0005-1

Reason for Recall

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

Details

Recalling Firm
Sprayology
Units Affected
1,465 bottles
Distribution
Distributed Nationwide in the USA
Location
Gaithersburg, MD

Frequently Asked Questions

What product was recalled?
DigestivEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879.NDC 61096-0005-1. Recalled by Sprayology. Units affected: 1,465 bottles.
Why was this product recalled?
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 7, 2018. Severity: Moderate. Recall number: D-0113-2019.