Class II

Drug Recall: 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

Denison Pharmaceuticals, LLC · May 28, 2024

Reason for Recall

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

Distribution

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

Quantity Affected

113,544 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0557-2024

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.