August 2021 FDA Recall Drug by Remedyrepack Inc.
D-0754-2021 - A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on August 17, 2021 for the product Drug. The FDA reported the reason for recall as a 500 count bottle of carvedilol 25 mg tablets contained two paroxetine tablets, 40 mg. product was repackaged into 180 count bottles.. The product was distributed in Product was distributed to two medical facilities in VA and FL. and the recall is currently terminated.

Recall Number: D-0754-2021

Reason for Recall
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
Initiated
08-17-2021
Reported
09-01-2021
Quantity
4

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88536
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
RemedyRepack Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Product was distributed to two medical facilities in VA and FL.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-09-2022
Product Description About Product Description
Full technical description of the product.
Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repackaged by RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1826-01

Batch or Lot Expiration Information

Lot# B1273286-071521, Exp 07/31/2022