Recalls / Class I
Class ID-0047-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Sucralfate
- Generic name
- Sucralfate
- Active ingredient
- Sucralfate
- Route
- Oral
- NDC
- 66689-305
- FDA application
- ANDA211884
- Affected lot / code info
- Lot#: 810300, Exp 10/2023
Why it was recalled
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Recalling firm
- Firm
- VistaPharm LLC
- Manufacturer
- VistaPharm, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, N/A, Largo, Florida 33771-4809
Distribution
- Quantity
- 180 bottles
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2023-10-18
- FDA classified
- 2023-10-16
- Posted by FDA
- 2023-10-25
- Terminated
- 2024-04-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0047-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.