D-0110-2019 Class II Terminated
FDA drug recall D-0110-2019 was initiated by Sprayology on Oct 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 Apr 18, 2019). Affected quantity: 731 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 7, 2018
- Initiation Date
- Oct 9, 2018
- Termination Date
- Apr 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 731 bottles
Product Description
Bone Builder, Homeopathic Oral Spray, 1.38 fl. oz (41ml), Manufactured for Sprayology Gaithersburg. MD 20879. NDC 61096-0012-1 and Tester NDC 61096-1012-1
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0110-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026