Reported Mar 12, 2025 · Ongoing
Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC,…
Safecor Health, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Safecor Health, LLC · 4060 Business Park Dr Ste B · Columbus, OH · 43204-5047
Is this the product you have?
- Simethicone 20 mg per 0.3 mL Oral Syringe
- Delivers0.3 mL, Oral Drops
- Mfg ByRugby
- Pkg bySafecor Health, LLC, Columbus, OH 43204
- NDC00536130375
- Lot codes and dates
Lot #s: 24201295Exp 02/05/202524210364Exp 02/20/202524231720Exp 02/27/202524500770Exp 06/26/202524471182Exp 06/20/202525031031Exp 07/22/2025
- Amount recalled
- 10992 Oral Syringes
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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