February 2023 FDA Recall Drug by Rising Pharmaceuticals
D-0348-2023 - Failed Impurities/Degradation Specifications
This Class II drug recall was voluntarily initiated by Rising Pharmaceuticals on February 15, 2023 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0348-2023
Failed Impurities/Degradation Specifications
02-15-2023
03-01-2023
12,216 bottles (100 count each)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
RISING PHARMACEUTICALS
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide.
06-14-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01
Batch or Lot Expiration Information
Batch# : NB101596, Exp. 04/30/2023
