Multi-event January 2014 FDA Recall Drug by Dermamedics, L.l.c.

This Multi-event Class II drug recall was voluntarily initiated by Dermamedics, L.l.c. on January 10, 2014 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-1492-2014 TERMINATED D-1489-2014 TERMINATED D-1493-2014 TERMINATED D-1491-2014 TERMINATED D-1488-2014 TERMINATED D-1490-2014 TERMINATED D-1487-2014 TERMINATED D-1494-2014 TERMINATED D-1495-2014 TERMINATED

Recall Number: D-1492-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Initiated
01-10-2014
Reported
08-06-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dermamedics, L.L.C.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-14-2017
Product Description About Product Description
Full technical description of the product.
Dermamedics Post Procedure Cream 1 oz. containers in the Dermamedics Post-Laser Treatment System with a SKU number of DM 1019

Batch or Lot Expiration Information

Lot# all lot codes

Recall Number: D-1489-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Initiated
01-10-2014
Reported
08-06-2014
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dermamedics, L.L.C.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-14-2017
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# all lot codes

Recall Number: D-1493-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Initiated
01-10-2014
Reported
08-06-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dermamedics, L.L.C.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-14-2017
Product Description About Product Description
Full technical description of the product.
Dermamedics Calm and Correct Cream 2 oz. containers in the Dermamedics Post Medical Procedure Kit with a SKU number of SK1005

Batch or Lot Expiration Information

Lot# all lot codes

Recall Number: D-1491-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Initiated
01-10-2014
Reported
08-06-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dermamedics, L.L.C.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-14-2017
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# all lot codes

Recall Number: D-1488-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Initiated
01-10-2014
Reported
08-06-2014
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dermamedics, L.L.C.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-14-2017
Product Description About Product Description
Full technical description of the product.
Dermamedics Calm & Correct Cream in 2 oz. containers with SKU number DM1020.

Batch or Lot Expiration Information

Lot# all lot codes, .25 oz and 2 oz sizes

Recall Number: D-1490-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Initiated
01-10-2014
Reported
08-06-2014
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dermamedics, L.L.C.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-14-2017
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# all lot codes

Recall Number: D-1487-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Initiated
01-10-2014
Reported
08-06-2014
Quantity
unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dermamedics, L.L.C.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-14-2017
Product Description About Product Description
Full technical description of the product.
Dermamedics Post Procedure Cream, 1 ounce containers which were distributed with a SKU number of DM 1026

Batch or Lot Expiration Information

Lot# all lot codes

Recall Number: D-1494-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Initiated
01-10-2014
Reported
08-06-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dermamedics, L.L.C.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-14-2017
Product Description About Product Description
Full technical description of the 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 Complexion Repair Acne Travel Kit with a SKU number of CR1007.

Batch or Lot Expiration Information

Lot# all lot codes 30 ml and 50 ml

Recall Number: D-1495-2014

Reason for Recall
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Initiated
01-10-2014
Reported
08-06-2014
Quantity

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
67247
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Dermamedics, L.L.C.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-14-2017
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# all lot codes 30 ml and 50 ml