Diflorasone Diacetate Ointment
FDA Recall NDC 64980-124
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Diflorasone Diacetate (NDC 64980-124). A significant event, classified as Class III, was initiated on Jun 24, 2024 by Rising Pharma Holdings, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Jun 24, 2024
Jul 17, 2024
868 tubes
Recall Profile & Regulatory Data
Event ID
94854
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Rising Pharma Holding, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60
Batch or Lot Expiration Information
Lot# DI2303B, Exp 12/31/2024
Affected Packages Involved in this Recall
64980-124-15Product
64980-124-03Product
64980-124-45Product
64980-124-60Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
