Why it was recalled
Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Product description
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.
Lot numbers, UPCs & expiration codes
Lot #: H110940, Exp 08/13
Where it was sold
Nationwide and Puerto Rico
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-610-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 7, 2013
- FDA report date
- Jul 3, 2013
- Quantity
- 8,808 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hill Dermaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-610-2013, exactly as published.
Show all FDA fields
- City
- Sanford
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 65434
- Address
- 2650 S Mellonville Ave
- Code information
- Lot #: H110940, Exp 08/13
- Postal code
- 32773-9311
- Report date
- Jul 3, 2013
- Product type
- Drugs
- Recall number
- D-610-2013
- Classification
- Class III
- Recalling firm
- Hill Dermaceuticals, Inc.
- Product quantity
- 8,808 bottles
- Termination date
- Jul 19, 2013
- Reason for recall
- Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC 28105-149-04.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- May 7, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 21, 2013