Product: 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.
Reason for recall: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recall initiated: 20250217
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated