RemedyRepack Inc.: Drug Recall

Recall #D-0165-2025 · 12/02/2024

Class II: Risk

Recall Details

Recall Number: D-0165-2025
Classification: Class II
Product Type: Drug
Recalling Firm: RemedyRepack Inc.
Status: Ongoing
Date Initiated: 12/02/2024
Location: Indiana, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: a) 1,564 cards, b) 799 bottles

Reason for Recall

CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.

Product Description

Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA

Distribution Pattern

Nationwide in the US

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 06/26/2024

CGMP Deviations: Out of specification for dissolution
Class II: Risk 05/31/2024

Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

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.