FDA Recall D-0047-2024
VistaPharm LLC · Largo, FL
Class I — life-threatening Terminated 195 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16
Reason for recall
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Recall record
- Recall number
D-0047-2024- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA Nationwide
- Recall initiated
- 2023-10-18
- Classified by FDA Center
- 2023-10-16
- FDA published
- 2023-10-25
- Terminated
- 2024-04-30
- Recalling firm
- VistaPharm LLC
- Firm location
- Largo, FL
Drug identification
- Brand name(s)
- SUCRALFATE
- Generic name(s)
- SUCRALFATE
- Manufacturer(s)
- VistaPharm, LLC
- NDC(s)
66689-305- Route(s)
- ORAL