Denison Pharmaceuticals, LLC: Drug Recall

Recall #D-0557-2024 · 05/28/2024

Class II: Risk

Recall Details

Recall Number: D-0557-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Denison Pharmaceuticals, LLC
Status: Terminated
Date Initiated: 05/28/2024
Location: Lincoln, RI, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 113,544 bottles

Reason for Recall

cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

Product Description

Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02

Distribution Pattern

Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.

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 05/03/2023

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