Rising Pharma Holding, Inc.: Drug Recall

Recall #D-0222-2024 · 12/29/2023

Class II: Risk

Recall Details

Recall Number: D-0222-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Rising Pharma Holding, Inc.
Status: Ongoing
Date Initiated: 12/29/2023
Location: East Brunswick, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 47,976 bottles

Reason for Recall

Presence of Foreign Tablets/Capsules

Product Description

buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03

Distribution Pattern

Nationwide within the United States

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.