Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Dist
Summary
The FDA issued a Class I for Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles p by VistaPharm LLC. Reason: Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus..
Details
Source
Drug Recall
External ID
D-0047-2024
Action Date
2023-10-25
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot#: 810300, Exp 10/2023
Quantity Affected: 180 bottles
Reason for Recall
Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-18
Company
Largo, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 48 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
VistaPharm LLC has 11 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (VistaPharm LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does VistaPharm LLC have FDA actions?
VistaPharm LLC has 11 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0047-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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