Why it was recalled
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Product description
ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04
Lot numbers, UPCs & expiration codes
13E014A exp. 11/14, 13F02C exp 12/14.
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-1177-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 31, 2014
- FDA report date
- Apr 2, 2014
- Quantity
- 7,292 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hill Dermaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1177-2014, exactly as published.
Show all FDA fields
- City
- Sanford
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 67420
- Address
- 2650 S Mellonville Ave
- Code information
- 13E014A exp. 11/14, 13F02C exp 12/14.
- Postal code
- 32773-9311
- Report date
- Apr 2, 2014
- Product type
- Drugs
- Recall number
- D-1177-2014
- Classification
- Class III
- Recalling firm
- Hill Dermaceuticals, Inc.
- Product quantity
- 7,292 bottles
- Termination date
- Feb 3, 2015
- 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
- ROYAL PHARMACEUTICALS Derma-Smoothe/FS fluocinolone acetonide 0.01% (Scalp Oil), 4 fl.oz., Rx only Manufactured by: Hill Dermaceuticals for: Royal Pharmaceuticals NDC 68791-102-04
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jan 31, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 24, 2014