FDA-Drug2025-03-12Class II
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.
Safecor Health, LLC
Hazard
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Sold states
Nationwide in the USA
Affected count
10992 Oral Syringes
Manufactured in
4060 Business Park Dr Ste B, Columbus, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0251-2025Don't want to check this manually?
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