Reported Nov 16, 2016 · Terminated

Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1%…

Taro Pharmaceuticals U.S.A., 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: Taro Pharmaceuticals U.S.A., Inc. · 3 Skyline Dr · Hawthorne, NY · 10532-2174

Is this the product you have?

  • Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PRE-TREAT Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) 4.20 FL OZ (125mL) (NDC 51672-2126-0) and STEP 2 CLEANSE Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc)(0.6.80 FL OZ (200 mL) (NDC 51672-2125-5)
  • Distributed byTaro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC
Lot codes and dates
    • Lot #: E601
    • E602
    • E603
    • E604
    • E608
    • E609 - Exp. September 2017
    • E610 E611
    • Exp. October 2017
Amount recalled
17,100 kits

Where it was sold

  • Nationwide

Why it was recalled

Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.

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 Jun 6, 2018 · Data as of Sep 19, 7:12 PM UTC

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