Recalls / Class II
Class IID-1149-2023
Product
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
- Brand name
- Sucralfate
- Generic name
- Sucralfate
- Active ingredient
- Sucralfate
- Route
- Oral
- NDC
- 66689-305
- FDA application
- ANDA211884
- Affected lot / code info
- Lot #: 921100; Exp. 02/2025
Why it was recalled
Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
Recalling firm
- Firm
- VistaPharm LLC
- Manufacturer
- VistaPharm, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, Largo, Florida 33771-4809
Distribution
- Quantity
- 14,400 bottles
- Distribution pattern
- Distributed nationwide to 68 consignees in the U.S.
Timeline
- Recall initiated
- 2023-08-30
- FDA classified
- 2023-09-11
- Posted by FDA
- 2023-09-20
- Terminated
- 2024-07-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1149-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.