RemedyRepack Inc.: Drug Recall

Recall #D-0378-2025 · 03/24/2025

Class II: Risk

Recall Details

Recall Number: D-0378-2025
Classification: Class II
Product Type: Drug
Recalling Firm: RemedyRepack Inc.
Status: Ongoing
Date Initiated: 03/24/2025
Location: Indiana, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1,858 30-count blister cards

Reason for Recall

CGMP Deviations

Product Description

Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00

Distribution Pattern

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 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
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.