Class III
Terminated
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
This recall has been terminated (originally issued November 16, 2016).
- Recall Initiated
- May 26, 2016
- Posted
- November 16, 2016
- Recall Number
- D-0134-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 17,100 kits
- Firm Location
- Hawthorne, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Distribution
Nationwide
Lot / Code Info
Lot #: E601, E602, E603, E604, E608, E609 - Exp. September 2017; E610 E611, Exp. October 2017
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