Enforcement Report - Week of September 5, 2012
-
Back to Previous Page
Event Detail
| Event ID | 62803 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Galderma Laboratories, L.P. |
| City | Fort Worth |
| State | TX |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-15 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide and Puerto Rico. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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, | Lots J090181-H100089, J090181-J100096, and J090181-K100102. | Class III | Subpotent; fluocinolone acetonide. | 17,160 bottles | D-1660-2012 |
-







