Drug & medication recalls Moderate risk

The Harvard Drug Group recalls Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 1717…

Recall date
July 29, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0806-2021
FDA classification
Class II
Brand / firm
The Harvard Drug Group
Sold / distributed
CO, FL, MO, OH

Why it was recalled

Failed Dissolution Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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

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