D-0251-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- March 12, 2025
- Initiation Date
- February 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10992 Oral Syringes
Product Description
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 Pattern
Nationwide in the USA
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.