VistaPharm Recalls Sucralfate Oral Suspension Due to Bacillus Cereus Contamination
Medical Recalls
Sucralfate Oral Suspension Bottle and Label
VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1g/10mL, to the consumer level, due to Bacillus cereus contamination in the product.
The product is used as an antiulcer therapeutic and is packaged in a 16oz (414mL) PET Bottle with NDC 66689-305-16. The affected Sucralfate Oral Suspension lot is number 810300 with an expiration Date of October 31, 2023. The product can be identified with its product name Sucralfate Oral Suspension 1g per 10mL, which the product Lot No 810300 and expiration date of October 31, 2023, at the bottom right side of label. This Sucralfate Oral Suspension Lot was distributed Nationwide to three (3) distributors by wholesale.
The contractor, Inmar, will perform the recall process, which is notifying distributors by recall packet delivered by FEDEX Next Day Delivery and will receive an email notification as well. In addition, Inmar is arranging for the return of all recalled products. Distributors that have any bottles remaining from Sucralfate Oral Suspension Lot 810300, which is being recalled, should return it to Inmar via the instructions provided.
To date, VistaPharm LLC has not received any reports of adverse events related to this recall.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: FDA
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
Consumer Contact: -
Consumers with questions regarding this recall can contact Inmar at 1-800-967-5952 or by email to rxrecalls@Inmar.com.Office hours 9am to 5pm EST Monday thru Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
Risk Statement: In the population most at risk, the immunocompromised population, there is a reasonable probability that microbial contamination of the oral suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections.
Report a Problem With This Product
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
- Complete a paper Voluntary MedWatch form that can be mailed to the FDA.
- https://www.fda.gov/safety/report-problem-fda
- Call an FDA Consumer Complaint Coordinator.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.
You Are Leaving Us
This link is being provided as a convenience and for informational purposes only it is not an endorsement or an approval of any of the products, services or opinions of the corporation or organization or individual.
Recallinsider.com bears no responsibility for the accuracy, legality or content of the external site or for that of subsequent links.