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FDARecalled Mar 12, 2025 · #D-0251-2025

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.

Hazard

Class II — temporary health risk

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Description

Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes. Classification: Class II Distribution: Nationwide in the USA

Product details

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.
Type
Drugs
Manufacturer
Safecor Health, LLC
Model numbers
UPCs