FDA Drug Recalls

Recalls / Class II

Class IID-0121-2019

Product

Life Detoxer Homeopathic Oral Spray 1.38 fl. oz. (41 mL). Manufactured by Sprayology Gaithersburg, MD 20879NDC 61096-0023-1 and Tester NDC 61096-1023-1

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
1,473 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-0121-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.