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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

pH-D Feminine Health: Boric Acid Vaginal Suppositories Recalled for Lack of FDA Approval

Agency Publication Date: September 30, 2020
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Summary

Approximately 88,100 boxes of pH-D Feminine Health Boric Acid Vaginal Suppositories (600 mg) are being recalled because they were marketed without required FDA approval (NDA/ANDA). The recall affects multiple lot numbers and 24-count boxes distributed nationwide. Consumers who have these products should stop using them and contact their healthcare provider, as these products have not been evaluated by the FDA for safety or effectiveness.

Risk

The product is being marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), meaning the FDA has not verified its safety, quality, or effectiveness for its intended use. Using unapproved drug products may pose unknown health risks to consumers.

What You Should Do

  1. Identify your product by checking the packaging for 'pH-D Feminine Health Boric Acid Vaginal Suppositories' in 24-count boxes with UPC code 3 49597 00044 5.
  2. Check your box for the following affected lot numbers: 2PA20021, 2PA20061, D-160, D-155, D-162, or 7PA20071.
  3. Immediately stop using any suppositories from the affected lots.
  4. Contact your healthcare provider or pharmacist for guidance regarding the use of this product and to discuss alternative treatments.
  5. Return any unused product to the place of purchase for a refund and contact pH-D Feminine Health 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

๐Ÿ’ฐFull Refund

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

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

Affected Products

Product: pH-D Feminine Health Boric Acid Vaginal Suppositories (24-count, 600 mg)
UPC Codes:
349597000445
Lot Numbers:
2PA20021
2PA20061
D-160
D-155
D-162
7PA20071

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86405
Status: Resolved
Manufacturer: pH-D Feminine Health
Sold By: Retailers nationwide
Manufactured In: United States
Units Affected: a. 37,000 boxes; b. 45,000 boxes; c. 6,100 boxes
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 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.