The Recall Desk
LowFDA (Drugs)·D-0134-2017·Announced 2016-11-16

Taro Recalls Kamedis Dandruff Care Kits Due to Low Active Ingredient

Taro Pharmaceuticals is recalling 17,100 kits of Kamedis Bio-Herbal Dandruff Care System because the active ingredient, zinc pyrithione, was found to be subpotent.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The hazard is a subpotent active ingredient, which is a documentation and efficacy issue rather than a direct safety risk like contamination or injury.

Plain-English summary

Taro Pharmaceuticals U.S.A., Inc. is recalling 17,100 kits of the Kamedis BIO-HERBAL DANDRUFF CARE THERAPEUTIC 2-STEP DANDRUFF CARE SYSTEM. The affected products include Step 1 Pre-Treat Concentrated Botanical Scalp Lotion (0.1% Pyrithione Zinc) and Step 2 Cleanse Concentrated Botanical Dandruff Shampoo (1.0% Pyrithione Zinc). The recall is due to out-of-specification assay values on stability for the active ingredient, zinc pyrithione, indicating the product is subpotent.

The affected lots are E601, E602, E603, E604, E608, and E609 with an expiration date of September 2017, and lots E610 and E611 with an expiration date of October 2017. These products were distributed nationwide.

Consumers who have these products should stop using them and contact Taro Pharmaceuticals or their healthcare provider for further instructions.

The recalled product

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 Bot
Affected units
17,100

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

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

Distribution

Distributed nationwide across the United States.