openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 9
Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026
Labeling or packagingreason.labeling_packaging · v1.0.0
misbranded
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Code information
all lot codes, .25 oz and 2 oz sizes
Distribution pattern
Nationwide
drug · product 3 of 9
Dermamedics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of DM1016 and 0.25 containers with a SKU number of PS 1016; and Therametics Baby's Relief Calm and Repair Cream in 2 oz. containers with a SKU number of BR008.
Labeling or packagingreason.labeling_packaging · v1.0.0
misbranded
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Code information
all lot codes
Distribution pattern
Nationwide
drug · product 4 of 9
Dermamedics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of DM 1011 and Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002.
Labeling or packagingreason.labeling_packaging · v1.0.0
misbranded
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Code information
all lot codes
Distribution pattern
Nationwide
drug · product 8 of 9
Dermamedics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Dermamedics Complexion Repair Acne Treatment System Kit with SKU numbers of DM 1013 and DM 1025, respectively; Therametics Complexion Repair Topical Rehydrating Emulsion which was distributed in 50 ml containers with a SKU number of CR002 and in 50 ml containers in the Therametics Complexion Repair Acne Treatment System Kit with a SKU number of CR1005; and in 30 ml containers in the Therametics Complexion Repair Acne Travel Kit with a SKU number of CR1007.
Labeling or packagingreason.labeling_packaging · v1.0.0
misbranded
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Code information
all lot codes 30 ml and 50 ml
Distribution pattern
Nationwide
drug · product 9 of 9
Therametics Complexion Repair Topical Rehydrating Emulsion in 50 ml and 30 ml containers in the Complexion Repair Acne Treatment System Kit and the Complexion Repair Acne Travel Kit with SKU numbers of CR1005 and CR1007, respectively.
