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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Hazard
- 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.
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