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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Selenium Sulfide 2.25% Shampoo Recalled for Unsupported Expiration Date

Agency Publication Date: December 18, 2023
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Summary

Private Label Partners, Inc. is recalling 3,396 bottles of Selenium Sulfide 2.25% Shampoo because stability data for the product does not support the expiration date listed on the label. This recall affects 180mL bottles of the prescription-only shampoo manufactured for Bi-Coastal Pharma Int. LLC. Consumers are advised that the product may not maintain its expected strength or quality through the current printed expiration date.

Risk

Because the shampoo's shelf-life has not been properly verified, the medication may lose its effectiveness before the printed expiration date. This could result in ineffective treatment for skin or scalp conditions requiring prescription-strength selenium sulfide.

What You Should Do

  1. The recalled product is Selenium Sulfide 2.25% Shampoo (180mL bottle) manufactured for Bi-Coastal Pharma Int. LLC, identified by NDC 42582-900-06.
  2. Check your bottle to see if it belongs to Lot #220551 with an expiration date of 2/28/2025.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Selenium Sulfide 2.25% Shampoo (180mL)by Bi-Coastal Pharma Int. LLC
Variants: Rx Only
Lot Numbers:
220551 (Exp: 2/28/2025)
NDC:
42582-900-06

Manufactured for Bi-Coastal Pharma Int. LLC.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93616
Status: Active
Manufacturer: Private Label Partners, Inc.
Sold By: authorized distributors; pharmacies
Manufactured In: United States
Units Affected: 3,396 bottles
Distributed To: New Jersey

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 ยท 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.