FDA-Drug2021-09-29Class II

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

The Harvard Drug Group
Hazard

Failed Dissolution Specifications

Sold states
CO, FL, MO, OH
Affected count
1,632 cartons
Manufactured in
17187 N Laurel Park Dr Ste 300, Livonia, MI, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0806-2021

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