Why it was recalled
Subpotent; fluocinolone acetonide
Product description
Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04
Lot numbers, UPCs & expiration codes
Lot Numbers: -Body Oil: J100095 (exp 09/12), J100099 (exp 09/12), K100106 (exp 10/12), K100111 (exp 10/12), L100872 (exp 11/12), L100880 (exp 11/12), D110560 (exp 04/13).
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-1647-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 8, 2012
- FDA report date
- Aug 22, 2012
- Quantity
- 111,816 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hill Dermaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1647-2012, exactly as published.
Show all FDA fields
- City
- Sanford
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 62607
- Address
- 2650 S Mellonville Ave
- Code information
- Lot Numbers: -Body Oil: J100095 (exp 09/12), J100099 (exp 09/12), K100106 (exp 10/12), K100111 (exp 10/12), L100872 (exp 11/12), L100880 (exp 11/12), D110560 (exp 04/13).
- Postal code
- 32773-9311
- Report date
- Aug 22, 2012
- Product type
- Drugs
- Recall number
- D-1647-2012
- Classification
- Class III
- Recalling firm
- Hill Dermaceuticals, Inc.
- Product quantity
- 111,816 bottles
- Termination date
- Feb 10, 2015
- Reason for recall
- Subpotent; fluocinolone acetonide
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01%, Body Oil, 4 fl. oz. (118.28mL ), Rx only, FOR TOPICAL USE ONLY, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-150-04
- Distribution pattern
- Nationwide
- Recall initiation date
- May 8, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Aug 14, 2012