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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

Econazole Nitrate Cream Recalled for Manufacturing Deviations

Agency Publication Date: April 14, 2022
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Summary

Preferred Pharmaceuticals, Inc. is recalling 41 tubes of Econazole Nitrate Cream, 1%, a generic version of Spectazole used to treat fungal skin infections. The recall was initiated because the manufacturer, Teligent Pharma, Inc., is discontinuing its stability study program, which means the medication's effectiveness cannot be guaranteed through its expiration date. This recall affects products sold by Physician's Solution with an expiration date of January 1, 2023. No injuries or adverse incidents have been reported to date.

Risk

The discontinuation of stability testing creates a risk that the drug may not maintain its proper strength or quality until its expiration date. If the medication loses potency, it may fail to effectively treat the skin infection for which it was prescribed.

What You Should Do

  1. The recalled product is Econazole Nitrate Cream, 1% (Generic for Spectazole) in 30 gm tubes, labeled as Rx Only and manufactured by Teligent Pharma, Inc. for Preferred Pharmaceuticals, Inc.
  2. Check your medication tube and carton for NDC 68788-7406-03 and lot numbers A1122P or G1421N with an expiration date of 1/1/2023.
  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 Preferred Pharmaceuticals, Inc. 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: Econazole Nitrate Cream, 1% (30 gm tube)by Preferred Pharmaceuticals, Inc.
Variants: Generic for Spectazole, Rx Only
Lot Numbers:
A1122P (Exp. 1/1/2023)
G1421N (Exp. 1/1/2023)
NDC:
68788-7406-03

Distributed by The Physican's Solution; Manufactured by Teligent Pharma, Inc. for Preferred Pharmaceuticals, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89943
Status: Resolved
Manufacturer: Preferred Pharmaceuticals, Inc.
Sold By: Physician's Solution
Manufactured In: United States
Units Affected: 41 Tubes
Distributed To: California, Florida

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.