Why it was recalled
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Product description
Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16
Lot numbers, UPCs & expiration codes
Lot #: 921100; Exp. 02/2025
Where it was sold
Distributed nationwide to 68 consignees in the U.S.
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-1149-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 30, 2023
- FDA report date
- Sep 20, 2023
- Quantity
- 14,400 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm LLC
Original FDA data
Every field from FDA enforcement report D-1149-2023, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 92916
- Address
- 7265 Ulmerton Rd
- Code information
- Lot #: 921100; Exp. 02/2025
- Postal code
- 33771-4809
- Report date
- Sep 20, 2023
- Product type
- Drugs
- Recall number
- D-1149-2023
- Classification
- Class II
- Recalling firm
- VistaPharm LLC
- Product quantity
- 14,400 bottles
- Termination date
- Jul 26, 2024
- Reason for recall
- Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-305-16
- Distribution pattern
- Distributed nationwide to 68 consignees in the U.S.
- Recall initiation date
- Aug 30, 2023
- Initial firm notification
- Letter
- Center classification date
- Sep 11, 2023