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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

Golden State Medical Supply Inc.: Clobetasol Propionate Cream Recalled for Inconsistent Medication Levels

Agency Publication Date: August 13, 2020
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Summary

Golden State Medical Supply Inc. has voluntarily recalled two lots of Clobetasol Propionate Cream, USP, 0.05%, which were sold in 15g and 45g tubes. The recall was issued because a bulk lot used to manufacture these specific batches failed tests for content uniformity, meaning the medication may not be distributed evenly throughout the cream. This could result in a patient receiving too much or too little of the active ingredient in a single application. If you have this prescription medication, you should contact your doctor or pharmacist to discuss your treatment and return the product for a refund.

Risk

The failure in content uniformity means the concentration of the active steroid, clobetasol propionate, may vary significantly within the tube. This could lead to ineffective treatment of skin conditions if the dose is too low, or an increased risk of side effects if the concentration is higher than intended.

What You Should Do

  1. Check your prescription cream tubes to see if they match the affected products: Clobetasol Propionate Cream, USP, 0.05% in 15g tubes (NDC 60429-902-15) or 45g tubes (NDC 60429-902-45).
  2. Look for lot number AB28535 on 15g tubes or lot number AB40178 on 45g tubes, both with an expiration date of December 2021.
  3. Contact your healthcare provider or pharmacist immediately to report the use of the recalled product and to obtain a replacement prescription or medical advice.
  4. Return any unused portion of the recalled medication to the pharmacy where you purchased it to receive a refund.
  5. Contact the marketer, Golden State Medical Supply Inc., at their Camarillo, CA location for further questions regarding this recall.
  6. For additional information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund and healthcare consultation.

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

Affected Products

Product: Clobetasol Propionate Cream, USP, 0.05% (15g Tube)
Model:
NDC 60429-902-15
Recall #: D-1497-2020
Lot Numbers:
AB28535 (Exp. Dec. 2021)
Date Ranges: Expiration Date: Dec. 2021
Product: Clobetasol Propionate Cream, USP, 0.05% (45g Tube)
Model:
NDC 60429-902-45
Recall #: D-1497-2020
Lot Numbers:
AB40178 (Exp. Dec. 2021)
Date Ranges: Expiration Date: Dec. 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86129
Status: Resolved
Manufacturer: Golden State Medical Supply Inc.
Sold By: Pharmacies
Manufactured In: Canada, United States
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.