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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/Topical Products

Sodium Sulfacetamide Wash and Hydroquinone Cream Recalled for Subpotency

Agency Publication Date: September 20, 2021
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Summary

Monarch PCM, LLC is voluntarily recalling 9,610 units of Sodium Sulfacetamide (10%) Wash and Hydroquinone USP (4%) Skin Bleaching Cream. Testing revealed that these products were subpotent, meaning they may not contain the full amount of active ingredients or preservatives required to be effective. No incidents or injuries have been reported to date, but the manufacturer is recalling these lots as a precaution to ensure patient safety.

Risk

Because these medications are subpotent, they may not provide the full therapeutic benefit intended by your doctor, which could lead to ineffective treatment of skin conditions. There is also a risk that the preservative levels are too low to maintain the product's quality through its expiration date.

What You Should Do

  1. This recall affects Sodium Sulfacetamide (10%) Wash in 6 fl oz and 12 fl oz bottles, and Hydroquinone USP (4%) Skin Bleaching Cream in 1 oz tubes distributed in Ohio and Tennessee.
  2. Identify your product by checking the NDC and UPC codes on the packaging. For Sodium Sulfacetamide Wash, look for UPC 342808103065 (NDC 42808-103-06, Lot 21FP1737) or UPC 342808103126 (NDC 42808-103-12, Lot 21FP1738). For Hydroquinone Cream, look for UPC 369367174015 (NDC 69367-174-01, Lot 21FP1731). All affected lots have an expiration date of 05/2023.
  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 Monarch PCM, LLC for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for 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: Sodium Sulfacetamide (10%) Wash
Variants: 6 fl oz (177 mL), 12 fl oz (354.8 mL), 10%
UPC Codes:
342808103065
342808103126
Lot Numbers:
21FP1737 (Exp 05/2023)
21FP1738 (Exp 05/2023)
NDC:
42808-103-06
42808-103-12

Manufactured for Exact-Rx, Inc.

Product: Hydroquinone USP (4%) Skin Bleaching Cream
Variants: 1 oz (28.35g) tube, 4%
UPC Codes:
369367174015
Lot Numbers:
21FP1731 (Exp 05/2023)
NDC:
69367-174-01

Manufactured for Westminster Pharmaceuticals, LLC

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88598
Status: Resolved
Manufacturer: Monarch PCM, LLC
Sold By: Exact-Rx, Inc.; Westminster Pharmaceuticals, LLC; Pharmacies
Manufactured In: United States
Units Affected: 2 products (a) 3305 bottles; b) 840 bottles; 6305 tubes)
Distributed To: Ohio, Tennessee

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.