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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/Prescription Drugs

TRIOVA PHARMACEUTICALS LLC: Estriol USP Micronized 5 G Recalled for Organic Impurities

Agency Publication Date: May 29, 2020
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Summary

Triova Pharmaceuticals is recalling 210 grams of Estriol USP Micronized 5 G, a prescription drug. The recall was initiated because the product failed testing for organic impurities, meaning it is "out of specification" and may contain degradation products or impurities beyond safe levels. This recall affects one specific lot of the medication with an expiration date of December 2020.

Risk

The presence of organic impurities or degradation products in a prescription medication can reduce the drug's effectiveness or cause unexpected side effects. While no specific injuries have been reported, the medication no longer meets the safety and quality standards required for pharmaceutical use.

What You Should Do

  1. Check your medication container for 'Estriol USP Micronized 5 G' with NDC 71092-9977-02.
  2. Verify if your product matches Lot #17010401181119190927 with an expiration date of 12/2020.
  3. Immediately contact your healthcare provider or pharmacist for guidance if you have been using this medication.
  4. Return any unused portion of the recalled product to the pharmacy where it was purchased for a refund.
  5. Contact Triova Pharmaceuticals LLC at 115 W 3rd St Ste 720, Tulsa, OK 74103 for further instructions regarding this recall.
  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

Healthcare provider consultation and pharmacy return

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

Affected Products

Product: Estriol USP Micronized 5 G, Rx only
Model:
NDC 71092-9977-02
Recall #: D-1284-2020
Lot Numbers:
17010401181119190927 (Exp 12/2020)
1701040118111919092725200122 (Exp 12/2020)
Date Ranges: EXP 12/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85704
Status: Resolved
Manufacturer: TRIOVA PHARMACEUTICALS LLC
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 210 grams
Distributed To: Nationwide
Agency Last Updated: June 1, 2020

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.