Recalls / Class II
Class IID-0110-2019
Product
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
- Affected lot / code info
- All lots within expiry
Why it was recalled
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Recalling firm
- Firm
- Sprayology
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 18914 Bonanza Way, N/A, Gaithersburg, Maryland 20879-1512
Distribution
- Quantity
- 731 bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2018-10-09
- FDA classified
- 2018-10-30
- Posted by FDA
- 2018-11-07
- Terminated
- 2019-04-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0110-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.