FDA (Drugs) recall action 67247
The FDA (Drugs) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
The agency’s own wording, quoted from the enforcement report.
Dermamedics, L.L.C. is recalling Calm and Correct Serum because the product is an unapproved new drug and misbranded.
Dermamedics, L.L.C. is recalling Dermamedics and Therametics Complexion Repair Topical Rehydrating Emulsions because the FDA determined they are unapproved new drugs and misbranded.
Dermamedics, L.L.C. is recalling specific Complexion Repair Topical Rehydrating Emulsions because the FDA determined they are unapproved new drugs and misbranded.
Dermamedics, L.L.C. is recalling Post Procedure Cream because the FDA determined the product is an unapproved new drug and misbranded.
Dermamedics, L.L.C. is recalling Post Procedure Cream because the FDA determined the product is an unapproved new drug and misbranded.
Dermamedics, L.L.C. is recalling specific lots of Dermamedics and Therametics Baby's Relief Calm and Repair Cream because the products are unapproved new drugs and misbranded.
Dermamedics, L.L.C. is recalling Therametics Complexion Repair Topical Rehydrating Emulsion because the FDA determined the products are unapproved new drugs and misbranded.
Dermamedics, L.L.C. is recalling Calm & Correct Cream because the FDA determined the product is an unapproved new drug and misbranded.
Dermamedics, L.L.C. is recalling Calm and Correct Cream because the FDA determined the product is an unapproved new drug and misbranded.