RISING PHARMACEUTICALS: Drug Recall

Recall #D-0348-2023 · 02/15/2023

Class II: Risk

Recall Details

Recall Number: D-0348-2023
Classification: Class II
Product Type: Drug
Recalling Firm: RISING PHARMACEUTICALS
Status: Terminated
Date Initiated: 02/15/2023
Location: East Brunswick, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12,216 bottles (100 count each)

Reason for Recall

Failed Impurities/Degradation Specifications

Product Description

Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01

Distribution Pattern

Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide.

Other Recalls by RISING PHARMACEUTICALS

Class II: Risk 02/07/2022

Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
Class II: Risk 09/02/2021

Labeling: Incorrect Instructions

View all recalls by RISING PHARMACEUTICALS →

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.