Why it was recalled
Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
Product description
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.
Lot numbers, UPCs & expiration codes
all lot codes 30 ml and 50 ml
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1494-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 10, 2014
- FDA report date
- Aug 6, 2014
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dermamedics, L.L.C.
Original FDA data
Every field from FDA enforcement report D-1494-2014, exactly as published.
Show all FDA fields
- City
- Oklahoma City
- State
- OK
- Status
- Terminated
- Country
- United States
- Event ID
- 67247
- Address
- 755 Research Pkwy Ste 150
- Code information
- all lot codes 30 ml and 50 ml
- Postal code
- 73104-3621
- Report date
- Aug 6, 2014
- Product type
- Drugs
- Recall number
- D-1494-2014
- Classification
- Class II
- Recalling firm
- Dermamedics, L.L.C.
- Termination date
- Mar 14, 2017
- Reason for recall
- Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 10, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 29, 2014