Why it was recalled
Subpotent; fluocinolone acetonide.
Product description
Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04,
Lot numbers, UPCs & expiration codes
Lots J090181-H100089, J090181-J100096, and J090181-K100102.
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-1660-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 15, 2012
- FDA report date
- Sep 5, 2012
- Quantity
- 17,160 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Galderma Laboratories, L.P.
Original FDA data
Every field from FDA enforcement report D-1660-2012, exactly as published.
Show all FDA fields
- City
- Fort Worth
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 62803
- Address
- 14501 N Freeway Tx
- Code information
- Lots J090181-H100089, J090181-J100096, and J090181-K100102.
- Postal code
- 76177
- Report date
- Sep 5, 2012
- Product type
- Drugs
- Recall number
- D-1660-2012
- Classification
- Class III
- Recalling firm
- Galderma Laboratories, L.P.
- Product quantity
- 17,160 bottles
- Termination date
- Feb 22, 2013
- Reason for recall
- Subpotent; fluocinolone acetonide.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04,
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Aug 15, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 24, 2012