Rising Pharma Holding, Inc.

11 FDA enforcement actions

11 Total Recalls

0 Class I

9 Class II

2 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 10/07/2025 drug

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 drug

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

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

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

CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Class II: Risk 11/19/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II: Risk 11/19/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II: Risk 11/19/2024 drug

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class III: Low Risk 06/24/2024 drug

Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Class III: Low Risk 05/16/2024 drug

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.
Class II: Risk 12/29/2023 drug

Presence of Foreign Tablets/Capsules

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.