Status
Terminated
Drug Enforcement D-1660-2012
Subpotent; fluocinolone acetonide.
Classification
Class III
Report Date
September 5, 2012
Termination Date
February 22, 2013
Product Information
- 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,
- Product quantity
- 17,160 bottles
- Reason for recall
- Subpotent; fluocinolone acetonide.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico.
Location & Firm
- Recalling firm
- Galderma Laboratories, L.P.
- Address
-
14501 N Freeway Tx, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1660-2012
- Event ID
- 62803
- Recall initiation date
- August 15, 2012
- Center classification date
- August 24, 2012
- Code info
- Lots J090181-H100089, J090181-J100096, and J090181-K100102.
- More code info
- —