Recalls / Class III
Class IIID-0134-2017
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
- Affected lot / code info
- Lot #: E601, E602, E603, E604, E608, E609 - Exp. September 2017; E610 E611, Exp. October 2017
Why it was recalled
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Recalling firm
- Firm
- Taro Pharmaceuticals U.S.A., Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Skyline Dr, Hawthorne, New York 10532-2174
Distribution
- Quantity
- 17,100 kits
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-05-26
- FDA classified
- 2016-11-10
- Posted by FDA
- 2016-11-16
- Terminated
- 2018-06-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0134-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.