Exact FDA event identifier

Event 74730

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: May 26, 2016
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Taro Pharmaceuticals U.S.A., Inc.

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

D-0134-2017

Recall number: D-0134-2017
Initiated: May 26, 2016
Classification: Class III
Status: Terminated
Recalling firm: Taro Pharmaceuticals U.S.A., Inc.
Quantity: 17,100 kits

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: E601, E602, E603, E604, E608, E609 - Exp. September 2017; E610 E611, Exp. October 2017

Distribution pattern

Nationwide