Rising Pharma Holding, Inc.: Drug Recall

Recall #D-0541-2024 · 05/16/2024

Class III: Low Risk

Recall Details

Recall Number: D-0541-2024
Classification: Class III
Product Type: Drug
Recalling Firm: Rising Pharma Holding, Inc.
Status: Ongoing
Date Initiated: 05/16/2024
Location: East Brunswick, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Reason for Recall

Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.

Product Description

Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufactured by: Laurus Labs Limited, Anakapalli-531011, India, NDC 64980-411-10

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.