US Drug Recall Register
Class III · Low risk Terminated Initiated May 26, 2016 (10 years ago)

Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

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

What was recalled

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 by: Taro Pharmaceuticals U.S.A, Inc. Hawthorne, NY 10532. NDC

Recalling firm
Taro Pharmaceuticals U.S.A., Inc.
NDC code
51672-2126-0
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0134-2017

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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