Imprimis NJOF, LLC

21 FDA enforcement actions

21 Total Recalls

0 Class I

14 Class II

7 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 12/18/2025 drug

Presence of particulate matter - Glass like particles.
Class II: Risk 12/18/2025 drug

Presence of particulate matter - Glass like particles.
Class II: Risk 12/18/2025 drug

Presence of particulate matter - Glass like particles.
Class III: Low Risk 10/20/2025 drug

Subpotent Drug
Class III: Low Risk 07/09/2025 drug

Sub-Potent Drug: Subpotent assay results during stability testing.
Class II: Risk 07/09/2025 drug

Sub-Potent Drug: Subpotent assay results during stability testing.
Class III: Low Risk 02/24/2025 drug

Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Class II: Risk 05/14/2024 drug

Lack of Assurance of Sterility
Class II: Risk 05/14/2024 drug

Lack of Assurance of Sterility
Class II: Risk 05/14/2024 drug

Lack of Assurance of Sterility
Class II: Risk 05/14/2024 drug

Lack of Assurance of Sterility
Class II: Risk 05/14/2024 drug

Lack of Assurance of Sterility
Class II: Risk 05/14/2024 drug

Lack of Assurance of Sterility
Class II: Risk 05/14/2024 drug

Lack of Assurance of Sterility
Class II: Risk 05/14/2024 drug

Lack of Assurance of Sterility
Class II: Risk 04/10/2024 drug

Subpotent Drug
Class III: Low Risk 04/10/2024 drug

Out of specification for assay
Class III: Low Risk 10/03/2023 drug

Subpotent: Failing Test Results for Epinephrine
Class III: Low Risk 09/20/2023 drug

Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0% of label claim.
Class III: Low Risk 08/10/2023 drug

Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range.
Class II: Risk 12/17/2020 drug

Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.

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.