FDA Drug recall D-0134-2017
Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PR…
- FDA Drug
- Class III
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class III recall of Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM - Kamedis Bio-Herbal Dandruff Care 0.1% PYRITHIONE ZINC, STEP 1 PR… by Taro Pharmaceuticals U, citing subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0134-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-05-26 |
| Published | 2016-11-16 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Taro Pharmaceuticals U |
| Distribution | US |
Product
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
Reason
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Identifiers
| code_info | Lot #: E601, E602, E603, E604, E608, E609 - Exp. September 2017; E610 E611, Exp. October 2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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All Taro Pharmaceuticals U recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0134-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.