July 2021 FDA Recall Entacapone by The Harvard Drug Group
D-0806-2021 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by The Harvard Drug Group on July 29, 2021 for the product Entacapone. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in CO, FL, MO, OH and the recall is currently terminated.
Recall Number: D-0806-2021
Failed Dissolution Specifications
07-29-2021
09-29-2021
1,632 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
The Harvard Drug Group
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
CO, FL, MO, OH
02-19-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot, expiry: N00187, 05/2022; N00245, 06/2022; N00273, 07/2022; N00355, 11/2022
