Recall D-0251-2025

US Class II Ongoing · initiated 2025-02-17

Recalling firm

Safecor Health, LLC, OH

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.

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