RemedyRepack Inc.: Drug Recall

Recall #D-0754-2021 · 08/17/2021

Class II: Risk

Recall Details

Recall Number: D-0754-2021
Classification: Class II
Product Type: Drug
Recalling Firm: RemedyRepack Inc.
Status: Terminated
Date Initiated: 08/17/2021
Location: Indiana, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4

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.

Product Description

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

Distribution Pattern

Product was distributed to two medical facilities in VA and FL.

Other Recalls by RemedyRepack Inc.

Class II: Risk 04/22/2025

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Class II: Risk 03/24/2025

CGMP Deviations
Class II: Risk 01/24/2025

CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Class II: Risk 12/02/2024

CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II: Risk 06/26/2024

CGMP Deviations: Out of specification for dissolution

View all recalls by RemedyRepack Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.