Drug 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.
D-0251-2025
Product summary
- Event
- Event 96308
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10992 Oral Syringes
- Official record key
drug-enforcement:D-0251-2025
Official wording
Reason: Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Code information: 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.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.