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

Recall Number: D-0557-2024

Firm: Denison Pharmaceuticals, LLC

Classification: Class II

Status: Terminated

Report Date: 20240626

Initiation Date: 20240528

Termination Date: 20250826

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

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