RemedyRepack Inc.: Drug Recall

Recall #D-0098-2023 · 12/20/2022

Class II: Risk

Recall Details

Recall Number: D-0098-2023
Classification: Class II
Product Type: Drug
Recalling Firm: RemedyRepack Inc.
Status: Terminated
Date Initiated: 12/20/2022
Location: Indiana, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 132 Cards of 30 = 3960 Tablets

Reason for Recall

Failed Impurities/Degradation specifications

Product Description

Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00.

Distribution Pattern

Product was distributed to one 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.