Medications & Supplements/Prescription Drugs

Warfarin Sodium Tablets Recalled for Failed Impurity and Degradation Specs

Agency Publication Date: February 23, 2023

Summary

Rising Pharmaceuticals is recalling 12,216 bottles of Warfarin Sodium Tablets, USP (1 mg), a prescription blood thinner. The medication was found to contain impurities and degradation levels that do not meet required quality specifications. No injuries or adverse health incidents have been reported at this time.

Risk

The presence of impurities or degradation in blood-thinning medication may affect the drug's quality and performance. If the medication is less effective than intended, it could potentially lead to inconsistent treatment of blood clots.

What You Should Do

This recall involves 100-count bottles of Warfarin Sodium Tablets, USP 1 mg, distributed by Rising Health, LLC (NDC 57237-119-01).
Identify the affected product by checking the label for batch number NB101596 and an expiration date of 04/30/2023.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Rising Pharmaceuticals for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Warfarin Sodium Tablets, USP (1 mg)

Variants: 1 mg, 100-count bottle, Tablet

Lot Numbers:

NB101596 (Exp. 04/30/2023)

NDC:

57237-119-01

Distributed by Rising Health, LLC, Saddle Brook, NJ 07663; Recall #: D-0348-2023

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91713

Status: Resolved

Manufacturer: RISING PHARMACEUTICALS

Sold By: 16 distributors; 8 wholesalers

Manufactured In: United States

Units Affected: 12,216 bottles (100 count each)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves 100-count bottles of Warfarin Sodium Tablets, USP 1 mg, distributed by Rising Health, LLC (NDC 57237-119-01).

Identify the affected product by checking the label for batch number NB101596 and an expiration date of 04/30/2023.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Rising Pharmaceuticals for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.