Drug & medication recalls Moderate risk

Safecor Health, LLC recalls Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Co…

Recall date
February 17, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0251-2025
FDA classification
Class II
Brand / firm
Safecor Health, LLC
Sold / distributed
Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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