Why it was recalled
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose 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.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0251-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 17, 2025
- FDA report date
- Mar 12, 2025
- Quantity
- 10992 Oral Syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Safecor Health, LLC
Original FDA data
Every field from FDA enforcement report D-0251-2025, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Ongoing
- Country
- United States
- Event ID
- 96308
- Address
- 4060 Business Park Dr Ste B
- 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.
- Postal code
- 43204-5047
- Report date
- Mar 12, 2025
- Product type
- Drugs
- Recall number
- D-0251-2025
- Classification
- Class II
- Recalling firm
- Safecor Health, LLC
- Product quantity
- 10992 Oral Syringes
- Reason for recall
- Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 17, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 5, 2025