Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., ...
FDA Recall #D-0599-2024 — Class III — June 24, 2024
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
Reason for Recall
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Recalling Firm
Rising Pharma Holding, Inc. — East Brunswick, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
868 tubes
Distribution
Nationwide in the USA
Code Information
Lot #, DI2303B, Exp 12/31/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated