Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: S...
FDA Recall #D-0251-2025 — Class II — February 17, 2025
Product Description
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.
Recalling Firm
Safecor Health, LLC — Columbus, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
10992 Oral Syringes
Distribution
Nationwide in the USA
Code Information
Lot #s: 24201295, Exp 02/05/2025; 24210364, Exp 02/20/2025; 24231720, Exp 02/27/2025; 24500770, Exp 06/26/2025; 24471182, Exp 06/20/2025; 25031031, Exp 07/22/2025.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated