Why it was recalled
Subpotent; 22 month stability timepoint
Product description
Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04
Lot numbers, UPCs & expiration codes
Lot # D110550, Exp. 04/2013.
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-218-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 21, 2012
- FDA report date
- Apr 3, 2013
- Quantity
- 8,592 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hill Dermaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-218-2013, exactly as published.
Show all FDA fields
- City
- Sanford
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 64455
- Address
- 2650 S Mellonville Ave
- Code information
- Lot # D110550, Exp. 04/2013.
- Postal code
- 32773-9311
- Report date
- Apr 3, 2013
- Product type
- Drugs
- Recall number
- D-218-2013
- Classification
- Class III
- Recalling firm
- Hill Dermaceuticals, Inc.
- Product quantity
- 8,592 bottles
- Termination date
- May 28, 2013
- Reason for recall
- Subpotent; 22 month stability timepoint
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Derma-Smoothe/FS (fluocinolone acetonide) 0.01% Topical Oil(SCALP OIL), Rx only, FOR TOPICAL USE ONLY, NOT FOR ORAL, OPHTHALMIC, OR INTRAVAGINAL USE, Net Contents 118.28 mL (4 fl. oz.), Hill Dermaceuticals, Inc., Sanford, Florida --- NDC 28105-149-04
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 21, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Mar 22, 2013