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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/Topical Products

US Pharmaceuticals Inc.: Skin Protectants and Hydrocortisone Creams Recalled for Microbial Risk

Agency Publication Date: February 4, 2019
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Summary

Approximately 94,620 units of various skin protectant ointments and hydrocortisone creams, including Walgreens brand and Medline Remedy products, are being recalled. The recall was initiated because purified water used during manufacturing showed higher-than-allowed levels of aerobic microbial growth (bacteria). Using these products could potentially lead to skin infections or other health complications, particularly for individuals with weakened immune systems or those applying the cream to broken skin. Consumers should contact a healthcare professional if they have used these products and have concerns.

Risk

The water used in the manufacturing process exceeded safety specifications for microbial counts. This poses a risk of bacterial infection if the contaminated product is applied to the skin, especially on areas already irritated or injured.

What You Should Do

  1. Identify if you have the affected products by checking the packaging for these specific details: Soothe & Cool Protect Moisture Guard (NDC 53329-303-22), Walgreens Hydrocortisone Cream 1% (NDC 0363-0237-03), or Medline Remedy Essential Barrier Skin Protectant (NDC 53329-302-14 or 53329-302-41).
  2. Check the lot numbers and expiration dates on your product tubes. Affected lots include: Soothe & Cool (50G17, 76J17, Exp. 5/2019 or 7/2019); Walgreens Hydrocortisone (36G17, 47G17, 84J17, Exp. 5/2019 or 7/2019); and Medline Remedy (44G17, Exp. 05/2019).
  3. Immediately stop using any products that match the identified lot numbers.
  4. Contact your healthcare provider or pharmacist for guidance if you have already used the product and are concerned about your health.
  5. Return any unused product to the place of purchase for a refund and contact the manufacturer, US Pharmaceuticals Inc. in Belleville, New Jersey, for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Refund and Healthcare Consultation

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

Affected Products

Product: Soothe & Cool Protect Moisture Guard Skin Protectant (3.5 oz)
Model:
NDC 53329-303-22
Recall #: D-0425-2019
Lot Numbers:
50G17 (Exp. 5/2019)
76J17 (Exp. 7/2019)
Date Ranges: Expiration 5/2019, Expiration 7/2019
Product: Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing (2 oz)
Model:
NDC 0363-0237-03
Recall #: D-0426-2019
Lot Numbers:
36G17 (Exp. 5/2019)
47G17 (Exp. 5/2019)
84J17 (Exp. 7/2019)
Date Ranges: Expiration 5/2019, Expiration 7/2019
Product: Medline Remedy Essential Barrier Skin Protectant Ointment (2 oz)
Model:
NDC 53329-302-14
Recall #: D-0427-2019
Lot Numbers:
44G17 (Exp. 05/2019)
Date Ranges: Expiration 05/2019
Product: Medline Remedy Essential Barrier Skin Protectant Ointment (6 oz)
Model:
NDC 53329-302-41
Recall #: D-0427-2019
Lot Numbers:
44G17 (Exp. 05/2019)
Date Ranges: Expiration 05/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81784
Status: Resolved
Manufacturer: US Pharmaceuticals Inc.
Sold By: Walgreens; Medline Industries, Inc.
Manufactured In: United States
Units Affected: 3 products (19752 units; 67848 units; 7020 units)
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.