RemedyRepack Inc.: Drug Recall

Recall #D-0366-2022 · 12/30/2021

Class II: Risk

Recall Details

Recall Number: D-0366-2022
Classification: Class II
Product Type: Drug
Recalling Firm: RemedyRepack Inc.
Status: Terminated
Date Initiated: 12/30/2021
Location: Indiana, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 56 Blister Cards

Reason for Recall

CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.

Product Description

Metformin 750 mg Extended Release NDC # 70518-2920-00

Distribution Pattern

Product was distributed to one direct account in PA.

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.