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 Calm & Correct Cream in 2 oz. containers with SKU number DM1020.
Lot numbers, UPCs & expiration codes
all lot codes, .25 oz and 2 oz sizes
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-1488-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 10, 2014
- FDA report date
- Aug 6, 2014
- Quantity
- unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dermamedics, L.L.C.
Original FDA data
Every field from FDA enforcement report D-1488-2014, 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, .25 oz and 2 oz sizes
- Postal code
- 73104-3621
- Report date
- Aug 6, 2014
- Product type
- Drugs
- Recall number
- D-1488-2014
- Classification
- Class II
- Recalling firm
- Dermamedics, L.L.C.
- Product quantity
- unknown
- 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 Calm & Correct Cream in 2 oz. containers with SKU number DM1020.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 10, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 29, 2014