Reported Sep 5, 2012 · Terminated

Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz…

Galderma Laboratories, LP

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Galderma Laboratories, L.P. · 14501 N Freeway Tx · Fort Worth, TX · 76177

Is this the product you have?

  • Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle
  • Marketed byGalderma Laboratories, LP, Fort Worth, TX, Mfd
  • byHill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04
Lot codes and dates
    • Lots J090181-H100089
    • J090181-J100096
    • and J090181-K100102
Amount recalled
17,160 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Subpotent; fluocinolone acetonide.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 22, 2013 · Data as of Sep 19, 4:59 PM UTC

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