Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.

Recall Number: D-0251-2025

Firm: Safecor Health, LLC

Classification: Class II

Status: Ongoing

Report Date: 20250312

Initiation Date: 20250217

Termination Date:

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.

Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.