Rising Pharma Holding, Inc.: Drug Recall

Recall #D-0599-2024 · 06/24/2024

Class III: Low Risk

Recall Details

Recall Number: D-0599-2024
Classification: Class III
Product Type: Drug
Recalling Firm: Rising Pharma Holding, Inc.
Status: Ongoing
Date Initiated: 06/24/2024
Location: East Brunswick, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 868 tubes

Reason for Recall

Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.

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

Distribution Pattern

Nationwide in the USA

Other Recalls by Rising Pharma Holding, Inc.

Class II: Risk 10/07/2025

Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Entacapone film-coated tablets (25 mg/100 mg/200 mg).
Class II: Risk 03/05/2025

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II: Risk 12/30/2024

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II: Risk 12/30/2024

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II: Risk 12/30/2024

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.

View all recalls by Rising Pharma Holding, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.