Drug product
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,
D-1660-2012
Product summary
- Event
- Event 62803
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,160 bottles
- Official record key
drug-enforcement:D-1660-2012
Official wording
Reason: Subpotent; fluocinolone acetonide.
Code information: Lots J090181-H100089, J090181-J100096, and J090181-K100102.
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Subpotent