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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

Spectrum Laboratory Products: Estriol Micronized Recalled Due to Subpotency Issues

Agency Publication Date: December 23, 2019
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Summary

Spectrum Laboratory Products has recalled approximately 6.2 kilograms of Estriol Micronized (USP), a hormonal medication used in prescription compounding. This recall was initiated because the supplier reported that testing results showed the drug was subpotent, meaning it did not meet the required strength specifications. Using a subpotent medication can lead to reduced effectiveness of the prescribed treatment, which may not provide the intended therapeutic benefits to patients.

Risk

The drug's active ingredients are lower than specified levels, which means patients may receive a lower dose of Estriol than their healthcare provider intended. This could result in ineffective treatment of hormonal conditions.

What You Should Do

  1. Locate your Estriol Micronized container and check for the following lot numbers: 1HG0308, 1HH0630, 1HI0854, 4HL0005, 4HL0036, or 4IH0032.
  2. Verify if the expiration date on your bottle is 04/16/2021.
  3. Check the bottle size and material; affected units include 1G, 5G, 25G, 100G, and 500G glass bottles, as well as 1KG plastic bottles.
  4. If your product matches these identifiers, contact your healthcare provider or pharmacist immediately to discuss your treatment and potential health impacts.
  5. Return any unused portions of the recalled medication to the pharmacy or place of purchase to obtain a refund.
  6. Contact Spectrum Laboratory Products directly for further instructions on returning the product and processing your refund.
  7. For additional information, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and refund

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

Affected Products

Product: Estriol Micronized, USP (1 G glass bottle)
Model:
D-0628-2020
Lot Numbers:
1HG0308 (Exp. 04/16/2021)
1HH0630 (Exp. 04/16/2021)
1HI0854 (Exp. 04/16/2021)
4HL0005 (Exp. 04/16/2021)
4HL0036 (Exp. 04/16/2021)
4IH0032 (Exp. 04/16/2021)
Date Ranges: Expiration date 04/16/2021
Product: Estriol Micronized, USP (5 G glass bottle)
Model:
D-0628-2020
Lot Numbers:
1HG0308 (Exp. 04/16/2021)
1HH0630 (Exp. 04/16/2021)
1HI0854 (Exp. 04/16/2021)
4HL0005 (Exp. 04/16/2021)
4HL0036 (Exp. 04/16/2021)
4IH0032 (Exp. 04/16/2021)
Date Ranges: Expiration date 04/16/2021
Product: Estriol Micronized, USP (25 G glass bottle)
Model:
D-0628-2020
Lot Numbers:
1HG0308 (Exp. 04/16/2021)
1HH0630 (Exp. 04/16/2021)
1HI0854 (Exp. 04/16/2021)
4HL0005 (Exp. 04/16/2021)
4HL0036 (Exp. 04/16/2021)
4IH0032 (Exp. 04/16/2021)
Date Ranges: Expiration date 04/16/2021
Product: Estriol Micronized, USP (100 G glass bottle)
Model:
D-0628-2020
Lot Numbers:
1HG0308 (Exp. 04/16/2021)
1HH0630 (Exp. 04/16/2021)
1HI0854 (Exp. 04/16/2021)
4HL0005 (Exp. 04/16/2021)
4HL0036 (Exp. 04/16/2021)
4IH0032 (Exp. 04/16/2021)
Date Ranges: Expiration date 04/16/2021
Product: Estriol Micronized, USP (500 G glass bottle)
Model:
D-0628-2020
Lot Numbers:
1HG0308 (Exp. 04/16/2021)
1HH0630 (Exp. 04/16/2021)
1HI0854 (Exp. 04/16/2021)
4HL0005 (Exp. 04/16/2021)
4HL0036 (Exp. 04/16/2021)
4IH0032 (Exp. 04/16/2021)
Date Ranges: Expiration date 04/16/2021
Product: Estriol Micronized, USP (1 KG plastic bottle)
Model:
D-0628-2020
Lot Numbers:
1HG0308 (Exp. 04/16/2021)
1HH0630 (Exp. 04/16/2021)
1HI0854 (Exp. 04/16/2021)
4HL0005 (Exp. 04/16/2021)
4HL0036 (Exp. 04/16/2021)
4IH0032 (Exp. 04/16/2021)
Date Ranges: Expiration date 04/16/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84509
Status: Resolved
Manufacturer: Spectrum Laboratory Products
Sold By: Spectrum Chemical Mfg Corp.; Pharmacies
Manufactured In: United States
Units Affected: 6.284 kg
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.