Medium RiskFDA Drug

Dermamedics, L.L.C.: Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

Agency Publication Date: July 29, 2014

Affected Products

Product: Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026

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Product: Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.

all lot codes, .25 oz and 2 oz sizes

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Product: 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.

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Product: 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.

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Product: Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068.

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Product: Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019

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Product: Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005

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Product: 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 Comple

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Product: 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.

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 67247

Status: Resolved

Manufacturer: Dermamedics, L.L.C.

Manufactured In: United States

Units Affected: 4 products (unknown; unknown; unknown; unknown)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026

all lot codes

Lot Numbers:

codes

Product: Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.

all lot codes, .25 oz and 2 oz sizes

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codes

all lot codes

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all lot codes

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Product: Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068.

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Product: Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019

all lot codes

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Product: Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005

all lot codes

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all lot codes 30 ml and 50 ml

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all lot codes 30 ml and 50 ml

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