FDA Drug Moderate Class II Terminated

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

Reported: March 1, 2023 Initiated: February 15, 2023 #D-0348-2023

Product Description

Reason for Recall

Failed Impurities/Degradation Specifications

Details

Recalling Firm: RISING PHARMACEUTICALS
Units Affected: 12,216 bottles (100 count each)
Distribution: Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide.
Location: East Brunswick, NJ

Frequently Asked Questions

What product was recalled? ▼

Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01. Recalled by RISING PHARMACEUTICALS. Units affected: 12,216 bottles (100 count each).

Why was this product recalled? ▼

Failed Impurities/Degradation Specifications

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on March 1, 2023. Severity: Moderate. Recall number: D-0348-2023.