Why it was recalled
Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: E601, E602, E603, E604, E608, E609 - Exp. September 2017; E610 E611, Exp. October 2017
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0134-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 26, 2016
- FDA report date
- Nov 16, 2016
- Quantity
- 17,100 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
Original FDA data
Every field from FDA enforcement report D-0134-2017, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 74730
- Address
- 3 Skyline Dr
- Code information
- Lot #: E601, E602, E603, E604, E608, E609 - Exp. September 2017; E610 E611, Exp. October 2017
- Postal code
- 10532-2174
- Report date
- Nov 16, 2016
- Product type
- Drugs
- Recall number
- D-0134-2017
- Classification
- Class III
- Recalling firm
- Taro Pharmaceuticals U.S.A., Inc.
- Product quantity
- 17,100 kits
- Termination date
- Jun 6, 2018
- Reason for recall
- Subpotent Drug: Out of Specification assay values on stability for the active ingredient, zinc pyrithione.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- May 26, 2016
- Initial firm notification
- Letter
- Center classification date
- Nov 10, 2016