Recall: D-0806-2021

Class II - Potentially Harmful

Class IIClassification

2021-07-29Initiated

TerminatedStatus

The Harvard Drug GroupFirm

Product

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

Reason

Failed Dissolution Specifications

Distribution

CO, FL, MO, OH

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.