FDAClass IIMarch 1, 2023

Warfarin Sodium Tablets recall: Impurity Out of Spec

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

Why was Warfarin Sodium Tablets recalled?

Failed Impurities/Degradation Specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Batch #: NB101596, Exp. 04/30/2023

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
Recalling firm
RISING PHARMACEUTICALS
Quantity
12,216 bottles (100 count each)
Distribution
Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide.
Recall date
March 1, 2023
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls