FDA Drug Recalls

Recalls / Class II

Class IID-0188-2020

Product

Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, Kim Kaufman Productions Nashville, TN.

Affected lot / code info
ALL

Why it was recalled

Marketed without an Approved NDA/ANDA

Recalling firm

Firm
Basic Reset Inc.
Notification channel
Letter
Type
FDA Mandated
Address
260 W Main St Ste 103, N/A, Hendersonville, Tennessee 37075-7316

Distribution

Quantity
N/A
Distribution pattern
United States including Puerto Rico and U.S. Virgin Islands, Canada, Nigeria, United Kingdom, Australia, Israel, Hungary, UAE, Mexico, Philippines, Greece

Timeline

Recall initiated
2019-10-18
FDA classified
2019-11-05
Posted by FDA
2019-11-13
Terminated
2021-10-27
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0188-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls