Reported Oct 30, 2013 · Terminated

Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC…

Tolmar, Inc.

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: Tolmar, Inc. · 701 Centre Ave · Fort Collins, CO · 80526-1843

Is this the product you have?

  • Ketoconazole Shampoo, 2%, Manufactured by TOLMAR Inc., Fort Collins, CO for Sandoz Inc., Princeton, NJ --- NDC 0781-7090-04.
Lot codes and dates
  • Lots
    • 6111A exp 8/14
    • 6191A exp 10/14
    • 5523A exp1/14
    • 5617A exp 2/14
    • 5619A exp2/14
    • 5660A exp 3/14
    • 5689A exp 3/14
    • 5690A exp 3/14
    • 6114A exp 9/14
    • 6115A exp 9/14
    • 6118A exp 9/14
    • 6122A exp 9/14
    • 5307A exp 8/13
    • 5391A exp 10/13
    • 5393A exp 10/13
    • 5392A exp 10/13
    • 5394A exp 10/13
    • 5396A exp 11/13
    • 5430A exp 11/13
    • 5431A exp 11/13
    • 5432A exp 11/13
    • 5434A exp 11/13
    • 5578A exp 11/13
    • 5491A exp 11/13
    • 5492A exp 11/13
    • 5493A exp 12/13
    • 5494A exp 12/13
    • 5531A exp 1/14 5661A exp 3/14
    • 5490A exp 11/13
    • 5533A exp 2/14
    • 5495A exp 12/13
    • 5534A exp 2/14
    • 5535A exp 2/14
    • 5621A exp 2/14
    • 5728A exp 3/14
    • 6117A exp 9/14
    • 6113A exp 9/14
    • 5776A exp 4/14
    • 6112A exp 8/14
    • 6119A exp 9/14
    • 6192A exp 10/14
    • and 6123A exp 10/14
Amount recalled
391,055 bottles

Where it was sold

  • Nationwide

Why it was recalled

Subpotent

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 Apr 10, 2014 · Data as of Sep 19, 8:08 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.