August 2012 FDA Recall Drug by Galderma Laboratories, L.p.
D-1660-2012 - Subpotent; fluocinolone acetonide.
This Class III drug recall was voluntarily initiated by Galderma Laboratories, L.p. on August 15, 2012 for the product Drug. The FDA reported the reason for recall as subpotent; fluocinolone acetonide.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1660-2012
Subpotent; fluocinolone acetonide.
08-15-2012
09-05-2012
17,160 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Galderma Laboratories, L.P.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico.
02-22-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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,
Batch or Lot Expiration Information
Lot# Lots J090181-H100089, J090181-J100096, and J090181-K100102.
