FDA Publish Date: September 22, 2023 Product: Sucralfate Oral Suspension 1g per 10mL Brand Name: VistaPharm Reason for Announcement: ...
FDA Publish Date: September 22, 2023Product: Sucralfate Oral Suspension 1g per 10mLBrand Name: VistaPharmReason for Announcement: Potential contamination with Bacillus cereus
What is Bacillus Cereus?Bacillus cereus is a bacterium that produces toxins that cause vomiting and diarrhea. It is a foodborne pathogen that can cause of gastrointestinal illness.
There is a reasonable probability that immunocompromised persons can result in life threatening infections such as endocarditis and necrotizing soft tissue infections.
The product is packaged in a 16oz (414mL) PET Bottle with NDC 66689-305-16. The lot is number 810300 with an expiration Date of October 31, 2023.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
