Reported Sep 29, 2021 · Terminated

Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals,…

The Harvard Drug Group

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: The Harvard Drug Group · 17187 N Laurel Park Dr Ste 300 · Livonia, MI · 48152-2600

Is this the product you have?

  • Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons
  • Distributed by
    • Major Pharmaceuticals
    • 17177 N. Laurel Park Dr
    • Suite 233
    • Livonia
    • MI 48152. NDC 0904-6822-04
Lot codes and dates
  • Lot
  • expiry
    • N00187
    • 05/2022
    • N00245
    • 06/2022
    • N00273
    • 07/2022
    • N00355
    • 11/2022
Amount recalled
1,632 cartons

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

Failed Dissolution Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 19, 2023 · Data as of Sep 19, 7:12 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.