Taro Pharmaceuticals U.S.A., Inc. recalls Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITH…

Recall date

May 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0134-2017

FDA classification

Class III

Brand / firm

Taro Pharmaceuticals U.S.A., Inc.

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

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