Medications & Supplements/Prescription Drugs

The Harvard Drug Group: Entacapone 200 mg Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: September 17, 2021

Summary

The Harvard Drug Group is recalling 1,632 cartons of Entacapone Tablets (USP, 200 mg), distributed under the brand Major Pharmaceuticals. This prescription medication is being recalled because it failed dissolution specifications, which means the medicine may not dissolve properly in the body as intended. These affected units were distributed in Colorado, Florida, Missouri, and Ohio. Consumers should check their prescription bottles to see if their medication is part of the impacted lots.

Risk

When a drug fails dissolution specifications, it may not release the active medication into the bloodstream at the correct rate or amount. This can lead to the medication being less effective than prescribed for managing Parkinson's disease symptoms.

What You Should Do

Check your medication carton and bottle for Entacapone Tablets, USP, 200 mg, distributed by Major Pharmaceuticals with NDC 0904-6822-04.
Look for the following lot numbers and expiration dates: Lot N00187 (Exp 05/2022), Lot N00245 (Exp 06/2022), Lot N00273 (Exp 07/2022), and Lot N00355 (Exp 11/2022).
If you have an affected product, contact your healthcare provider or pharmacist for guidance before you stop taking the medication.
Return any unused product from these specific lots to your pharmacy for a refund and contact The Harvard Drug Group for further instructions.
For additional questions or to report a complaint, 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: Entacapone Tablets, USP, 200 mg (30 Tablets per unit dose carton)

Model:

NDC 0904-6822-04

Recall #: D-0806-2021

Lot Numbers:

N00187 (Exp 05/2022)

N00245 (Exp 06/2022)

N00273 (Exp 07/2022)

N00355 (Exp 11/2022)

Date Ranges: 05/2022, 06/2022, 07/2022, 11/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88638

Status: Resolved

Manufacturer: The Harvard Drug Group

Sold By: Major Pharmaceuticals; Pharmacies

Manufactured In: United States

Units Affected: 1,632 cartons

Distributed To: Colorado, Florida, Missouri, Ohio

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.

Summary

What You Should Do

Check your medication carton and bottle for Entacapone Tablets, USP, 200 mg, distributed by Major Pharmaceuticals with NDC 0904-6822-04.

Look for the following lot numbers and expiration dates: Lot N00187 (Exp 05/2022), Lot N00245 (Exp 06/2022), Lot N00273 (Exp 07/2022), and Lot N00355 (Exp 11/2022).

If you have an affected product, contact your healthcare provider or pharmacist for guidance before you stop taking the medication.

Return any unused product from these specific lots to your pharmacy for a refund and contact The Harvard Drug Group for further instructions.

For additional questions or to report a complaint, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.