Denison Pharmaceuticals, LLC

8 FDA enforcement actions

8 Total Recalls

0 Class I

6 Class II

2 Class III

Firm Details

Product Types: drug
States: RI

All Recalls

Class II: Risk 02/24/2025 drug

Chemical Contamination: Presence of benzene.
Class III: Low Risk 09/25/2024 drug

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class III: Low Risk 09/25/2024 drug

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Class II: Risk 05/28/2024 drug

cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Class II: Risk 05/03/2023 drug

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II: Risk 05/03/2023 drug

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II: Risk 05/03/2023 drug

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Class II: Risk 05/03/2023 drug

CGMP Deviations: Use of non-food grade lubricant in mixing vessel.

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.