Denison Pharmaceuticals, LLC: Drug Recall

Recall #D-0775-2023 · 05/03/2023

Class II: Risk

Recall Details

Recall Number: D-0775-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Denison Pharmaceuticals, LLC
Status: Ongoing
Date Initiated: 05/03/2023
Location: Lincoln, RI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 13,968 bottles

Reason for Recall

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

Product Description

Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.

Distribution Pattern

Product was distributed Nationwide.

Other Recalls by Denison Pharmaceuticals, LLC

Class II: Risk 02/24/2025

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

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

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

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

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

View all recalls by Denison Pharmaceuticals, LLC →

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.