RemedyRepack Inc.: Drug Recall

Recall #D-0788-2022 · 04/06/2022

Class II: Risk

Recall Details

Recall Number: D-0788-2022
Classification: Class II
Product Type: Drug
Recalling Firm: RemedyRepack Inc.
Status: Terminated
Date Initiated: 04/06/2022
Location: Indiana, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 433/30 count blister cards, 33/60 count blister cards

Reason for Recall

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.

Product Description

Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.

Distribution Pattern

Product was distributed to customers in AK and 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.