Class IIReported 2025-03-12

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.

Recalled by Safecor Health, LLC

Reason for Recall

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

Recall Number

D-0251-2025

Classification

Class II

Status

Ongoing

Category

drug

Initiated

2025-02-17

Reported

2025-03-12

Distribution

Nationwide in the USA

Code Info

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.

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.