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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Acella Sodium Sulfacetamide Cleansing Pads Recalled for Low Potency

Agency Publication Date: December 1, 2022
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Summary

Acella Pharmaceuticals, LLC is recalling 528 cartons of Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads because the medication was found to be subpotent. This means the prescription drug (Sodium Sulfacetamide and Sulfur) may not contain the full amount of active ingredients required by the end of its 24-month shelf life. No injuries or adverse events have been reported to date. These cleansing pads were distributed nationwide to pharmacies in cartons containing sixty 3.7g pads each.

Risk

Using a subpotent medication may result in the product being less effective at treating the skin conditions for which it was prescribed. This could lead to a lack of improvement or a worsening of the symptoms being treated.

What You Should Do

  1. This recall involves Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads (3.7g pads, 60 per carton) distributed by Acella Pharmaceuticals with NDC 42192-113-60.
  2. Check your product packaging for lot numbers 21084 or 21085 with an expiration date of 06/30/2023.
  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 Acella Pharmaceuticals, LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 or visit www.fda.gov/safety/recalls for more information.

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: Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads (3.7g)
Variants: 10% Sodium Sulfacetamide, 4% Sulfur, 60 cleansing pads per carton, Rx Only
Lot Numbers:
21084 (Exp 06/30/2023)
21085 (Exp 06/30/2023)
NDC:
42192-113-60

Manufactured for Acella Pharmaceuticals, LLC Alpharetta, GA 30005

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91150
Status: Resolved
Manufacturer: Acella Pharmaceuticals, LLC
Sold By: pharmacies
Manufactured In: United States
Units Affected: 528 cartons
Distributed To: Nationwide

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.