Why it was recalled
Subpotent; fluocinolone acetonide
Product description
Derma-Smoothe/FS (Fluocinolone Acetonide) 0.01% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04
Lot numbers, UPCs & expiration codes
Lot Numbers: -Scalp Oil: H100084 (exp 08/12), H100086 (08/12), J100093 (exp 08/12), J100094 (exp 09/12), J100097 (exp 09/12), K100101 (exp 09/12), K100103 (exp 10/12), K100104 (exp 10/12), K100108 (exp 10/12), K100112 (exp 10/12), L100860 (exp 11/12), L100890 (exp 11/12), L100910 (exp 11/12).
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-1646-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 8, 2012
- FDA report date
- Aug 22, 2012
- Quantity
- 161,064 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hill Dermaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1646-2012, 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: -Scalp Oil: H100084 (exp 08/12), H100086 (08/12), J100093 (exp 08/12), J100094 (exp 09/12), J100097 (exp 09/12), K100101 (exp 09/12), K100103 (exp 10/12), K100104 (exp 10/12), K100108 (exp 10/12), K100112 (exp 10/12), L100860 (exp 11/12), L100890 (exp 11/12), L100910 (exp 11/12).
- Postal code
- 32773-9311
- Report date
- Aug 22, 2012
- Product type
- Drugs
- Recall number
- D-1646-2012
- Classification
- Class III
- Recalling firm
- Hill Dermaceuticals, Inc.
- Product quantity
- 161,064 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% Topical Oil (Scalp Oil), 4 fl oz (118.28mL) bottle, Rx only, FOR TOPICAL USE ONLY NOT, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA --- NDC 28105-149-04
- 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