FDA Drug Recalls

Recalls / Class II

Class IID-0447-2023

Product

Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854

Affected lot / code info
Lot #: 2E021A, Exp. Date Jan-25

Why it was recalled

CGMP DEVIATIONS

Recalling firm

Firm
Ecometics, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
19 Concord St, Norwalk, Connecticut 06854-3706

Distribution

Quantity
4,210 metal tubes/folding carton
Distribution pattern
Nationwide within the United States

Timeline

Recall initiated
2023-02-24
FDA classified
2023-03-08
Posted by FDA
2023-03-15
Terminated
2023-06-21
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0447-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.