FDAHealthFebruary 17, 2025
Safecor Health, LLC — 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.
⚠️ Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 17, 2025
Nationwide in the USA
What's affected?
- 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.
- Brand
- Safecor Health, LLC
- Lot code
- 24201295
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 10992 Oral Syringes.
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