D-0113-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- November 7, 2018
- Initiation Date
- October 9, 2018
- Termination Date
- April 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,465 bottles
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.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
All lots within expiry