Medications & Supplements/Topical Products

A.P. Deauville, LLC: Soft Whisper Dandruff Shampoo Recalled for Water Specification Failures

Agency Publication Date: June 24, 2020

Summary

Approximately 82,800 bottles of Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc) have been recalled because they were manufactured using water that failed to meet required safety and quality standards. The 14.4 FL OZ bottles were produced under conditions that deviated from current Good Manufacturing Practices (cGMP), specifically regarding water testing specifications. Consumers should stop using the affected shampoo immediately and contact a healthcare provider if they have concerns about skin or eye irritation. This product was distributed across the United States.

Risk

The use of water that fails quality specifications during manufacturing can introduce microbial contamination or impurities into the product. This poses a potential risk for skin or eye infections and irritation, especially for individuals with broken skin or compromised immune systems.

What You Should Do

Identify your product: Check your 14.4 FL OZ (426 mL) bottle of Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc) for UPC 815195014097 and NDC 42913-020-00.
Check the lot and expiry: Locate the lot number on the packaging. Affected lot numbers are 070421E211, 070921E221, 071021E231, and 071021E241, all with an expiration date of July 2021 (Exp 7/2021).
Stop using the shampoo: If your bottle matches any of the lot numbers listed above, stop using it immediately to avoid potential irritation or infection.
Consult a professional: Contact your healthcare provider or pharmacist for guidance if you have used this product and are experiencing any adverse health effects.
Seek a remedy: Return any unused product to the pharmacy or place of purchase for a refund and contact A.P. Deauville, LLC for further instructions regarding the disposal or return of the shampoo.
Agency Contact: For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug product refund and health consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Soft Whisper by Powerstick Dandruff Shampoo (14.4 FL OZ)

Model:

NDC 42913-020-00

UPC Codes:

815195014097

Lot Numbers:

070421E211 (Exp 7/2021)

070921E221 (Exp 7/2021)

071021E231 (Exp 7/2021)

071021E241 (Exp 7/2021)

Date Ranges: Exp 7/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85806

Status: Resolved

Manufacturer: A.P. Deauville, LLC

Manufactured In: United States

Units Affected: 82,800 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify your product: Check your 14.4 FL OZ (426 mL) bottle of Soft Whisper by Powerstick Dandruff Shampoo (Pyrithione Zinc) for UPC 815195014097 and NDC 42913-020-00.

Check the lot and expiry: Locate the lot number on the packaging. Affected lot numbers are 070421E211, 070921E221, 071021E231, and 071021E241, all with an expiration date of July 2021 (Exp 7/2021).

Stop using the shampoo: If your bottle matches any of the lot numbers listed above, stop using it immediately to avoid potential irritation or infection.

Consult a professional: Contact your healthcare provider or pharmacist for guidance if you have used this product and are experiencing any adverse health effects.

Seek a remedy: Return any unused product to the pharmacy or place of purchase for a refund and contact A.P. Deauville, LLC for further instructions regarding the disposal or return of the shampoo.

Agency Contact: For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.