Recalls / Class II
Class IID-0251-2025
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.
- Affected lot / code info
- 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.
Why it was recalled
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Recalling firm
- Firm
- Safecor Health, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4060 Business Park Dr Ste B, Columbus, Ohio 43204-5047
Distribution
- Quantity
- 10992 Oral Syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-02-17
- FDA classified
- 2025-03-05
- Posted by FDA
- 2025-03-12
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0251-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.