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) 0.01% Topical Oil (Scalp Oil), 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
K111090 exp.10/13, K111122 exp10/13, K111140 exp.10/13, K111150 exp.10/13, 111180 exp.11/13, L111190 exp11/13, M111250 exp.12/13, M111270 exp.12/13, and M111292 exp.12/13
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-007-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 8, 2013
- FDA report date
- Nov 27, 2013
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hill Dermaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-007-2014, exactly as published.
Show all FDA fields
- City
- Sanford
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 66371
- Address
- 2650 S Mellonville Ave
- Code information
- K111090 exp.10/13, K111122 exp10/13, K111140 exp.10/13, K111150 exp.10/13, 111180 exp.11/13, L111190 exp11/13, M111250 exp.12/13, M111270 exp.12/13, and M111292 exp.12/13
- Postal code
- 32773-9311
- Report date
- Nov 27, 2013
- Product type
- Drugs
- Recall number
- D-007-2014
- Classification
- Class III
- Recalling firm
- Hill Dermaceuticals, Inc.
- Termination date
- Aug 4, 2014
- 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) 0.01% Topical Oil (Scalp Oil), 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
- Sep 8, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Nov 20, 2013