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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: Nifedipine Extended-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: July 9, 2021
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Summary

The Harvard Drug Group is recalling 876 cartons of Nifedipine Extended-Release Tablets (30 mg), a medication used to treat high blood pressure and chest pain, because the tablets failed routine stability testing for dissolution. When a drug fails dissolution testing, it means the medication may not release into the body at the intended rate, which can lead to the drug being less effective or causing unexpected side effects. Approximately 504 cartons of the 50-count dose and 372 cartons of the 100-count dose are affected by this recall.

Risk

If the medication does not dissolve properly, the patient may not receive the correct dose of Nifedipine over the intended timeframe. This could lead to poorly controlled blood pressure or an increase in chest pain (angina) incidents.

What You Should Do

  1. Check your medication packaging for Nifedipine Extended-Release Tablets, USP 30 mg with the following NDC numbers and Lot details: 100-count cartons (NDC 0904-7080-61, Lot N00418, Exp. 09/2022) or 50-count cartons (NDC 0904-7080-06, Lot N00417, Exp. 09/2022).
  2. Contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription if your medication is part of the recalled lots.
  3. Return any unused portions of the recalled medication to the pharmacy where you purchased it for a full refund.
  4. Contact The Harvard Drug Group at their headquarters in Livonia, Michigan, for further instructions regarding this recall.
  5. For additional questions or to report a problem, 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: NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg (100 count unit dose carton)
Model:
NDC 0904-7080-61
Recall #: D-0652-2021
Lot Numbers:
N00418 (Exp. 09/2022)
Date Ranges: Expiration 09/2022
Product: NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg (50 count unit dose carton)
Model:
NDC 0904-7080-06
Recall #: D-0652-2021
Lot Numbers:
N00417 (Exp. 09/2022)
Date Ranges: Expiration 09/2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88224
Status: Resolved
Manufacturer: The Harvard Drug Group
Sold By: Ingenus Pharmaceuticals, LLC; Major Pharmaceuticals
Manufactured In: United States
Units Affected: 504 Cartons of 50 count each; 372 Cartons of 100 count each
Distributed To: Ohio, New Jersey

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.