FDA recall D-0251-2025

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.

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2025-02-17

Report date

2025-03-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0251-2025