D-0111-2019 Class II Terminated
FDA drug recall D-0111-2019 was initiated by Sprayology on October 9, 2018 and is designated Class II. Reason for recall: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. The recall status is terminated (terminated April 18, 2019). Affected quantity: 4,153 bottles.
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
- 4,153 bottles
Product Description
AllergEase, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0003-1
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