Medications & Supplements/Topical Products

Diflorasone Diacetate Ointment Recalled for Impurity Specification Failure

Agency Publication Date: July 10, 2024

Summary

Rising Pharma Holding, Inc. is recalling 868 tubes of Diflorasone Diacetate Ointment, USP, 0.05% (60g tube) because the product failed to meet impurity limits during long-term stability testing. This prescription ointment is used to treat various skin conditions. The recall only affects lot number DI2303B with an expiration date of December 31, 2024.

Risk

Testing at the 12-month mark showed that impurity levels exceeded acceptable safety specifications. This degradation could potentially impact the effectiveness or safety of the medication.

What You Should Do

This recall affects 60g tubes of Diflorasone Diacetate Ointment, USP, 0.05% (NDC 64980-124-60) with lot number DI2303B and an expiration date of 12/31/2024.
If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist.
Return any unused product to the place of purchase for a refund, throw it away, or contact Rising Pharma Holding, Inc. directly 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: Diflorasone Diacetate Ointment, USP, 0.05% (60g tube)

Variants: 0.05%, 60g tube, Ointment, Rx only

Lot Numbers:

DI2303B (Exp 12/31/2024)

NDC:

64980-124-60

Recall #: D-0599-2024; Manufactured for Rising Pharmaceuticals, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94854

Status: Active

Manufacturer: Rising Pharma Holding, Inc.

Sold By: Pharmacies; Healthcare providers

Manufactured In: United States

Units Affected: 868 tubes

Distributed To: Nationwide

Agency Last Updated: July 16, 2024

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 affects 60g tubes of Diflorasone Diacetate Ointment, USP, 0.05% (NDC 64980-124-60) with lot number DI2303B and an expiration date of 12/31/2024.

If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist.

Return any unused product to the place of purchase for a refund, throw it away, or contact Rising Pharma Holding, Inc. directly for further instructions.

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