US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 29, 2021 (5 years ago)

Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Dissolution Specifications

What was recalled

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

Recalling firm
The Harvard Drug Group
NDC code
0904-6822-04
Origin
MI, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0806-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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