Drug 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
D-0134-2017
Product summary
- Event
- Event 74730
- Status
- Terminated
- Classification
- Class III
- Quantity
- 17,100 kits
- Official record key
drug-enforcement:D-0134-2017
Official wording
Reason: 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
Derived failure modes
-
Potency or specification failure
Subpotent