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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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Critical RiskFDA Drug
Medications & Supplements/Topical Products

Valor Compounding Pharmacy Nifedipine Ointment Recalled for Potency Issues

Agency Publication Date: July 22, 2022
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Summary

Valor Compounding Pharmacy is recalling five 60-gram tubes of Nifedipine (Nifedipine WSP 0.2%) Ointment because testing revealed incorrect potency levels. The medication was found to be both subpotent and superpotent, meaning it may contain significantly less or significantly more of the active ingredient than intended. If you have health concerns regarding this product, you should contact your healthcare provider or pharmacist. Return any unused product to the pharmacy for a refund, throw it away, or contact Valor Compounding Pharmacy for further instructions.

Risk

Incorrect medication potency can cause a patient to receive an inaccurate dose, leading to ineffective treatment of their condition or potential side effects from receiving too much medication. No incidents or injuries have been reported to date in connection with this recall.

What You Should Do

  1. This recall involves 60-gram tubes of Nifedipine WSP 0.2% Ointment prepared by Valor Compounding Pharmacy, marked with lot number 06162022@30 or 06162022 and a Beyond Use Date (BUD) of 12/13/2022.
  2. If you have health concerns, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Valor Compounding Pharmacy at 2461 Shattuck Ave., Berkeley, CA 94704 for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

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: Nifedipine WSP 0.2% Ointment (60 gram)
Variants: 0.2% Strength, 60 gram tube, Rx only
Lot Numbers:
06162022@30 (BUD 12/13/2022)
06162022

Compounded drug produced at 2461 Shattuck Ave., Berkeley, CA 94704.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90539
Status: Resolved
Manufacturer: Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy
Sold By: Valor Compounding Pharmacy
Manufactured In: United States
Units Affected: 5 (60 gram) tubes
Distributed To: California

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.