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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

The Harvard Drug Group: Doxycycline Hyclate Tablets Recalled for Failed Dissolution Test

Agency Publication Date: June 4, 2020
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Summary

The Harvard Drug Group is recalling approximately 16,443 cartons of Doxycycline Hyclate Tablets (100 mg), a prescription antibiotic used to treat bacterial infections. Testing conducted at the end of the product's shelf life revealed that the tablets failed to dissolve at the required rate. If an antibiotic does not dissolve properly in the body, it may not be fully absorbed, which can lead to the medication being less effective than intended or failing to treat an infection entirely. The affected products were distributed nationwide in unit dose cartons of 30 or 50 tablets.

Risk

The drug failed dissolution specifications, which means the tablets may not break down and release the active medication into the bloodstream as required. This defect could result in a patient receiving an inadequate dose of the antibiotic, potentially allowing an infection to persist or worsen.

What You Should Do

  1. Check your medication packaging for Doxycycline Hyclate Tablets, USP, 100 mg, distributed by Major Pharmaceuticals.
  2. Verify the NDC and lot numbers: For 3x10 unit dose cartons, look for NDC 0904-0430-04 and lot number R00828D (Exp. 08/2020).
  3. Verify the NDC and lot numbers: For 5x10 unit dose cartons, look for NDC 0904-0430-06 and lot numbers R00732D (Exp. 05/2020), R00783D (Exp. 06/2020), or R00827D (Exp. 08/2020).
  4. If you have an affected product, contact your healthcare provider or pharmacist immediately for guidance on continuing your treatment and to obtain a replacement.
  5. Return any unused medication to the pharmacy where you purchased it for a refund.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare consultation and pharmacy refund

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

Affected Products

Product: Doxycycline Hyclate Tablets, USP, 100 mg (3x10 unit dose cartons)
Model:
0904-0430-04
Lot Numbers:
R00828D (Exp. date 08/2020)
Date Ranges: Expiration date 08/2020
Product: Doxycycline Hyclate Tablets, USP, 100 mg (5x10 unit dose cartons)
Model:
0904-0430-06
Lot Numbers:
R00732D (Exp. date 05/2020)
R00783D (Exp. date 06/2020)
R00827D (Exp. date 08/2020)
Date Ranges: Expiration dates between 05/2020 and 08/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85757
Status: Resolved
Manufacturer: The Harvard Drug Group
Sold By: Major Pharmaceuticals; Pharmacies
Manufactured In: United States
Units Affected: 16,443 cartons
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 · 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.