VistaPharm LLC Announces Voluntary Recall of Sucralfate Oral Suspension Due to Microbial Contamination
VistaPharm LLC, based in Largo, Florida, has voluntarily initiated a recall of a specific lot of Sucralfate Oral Suspension, 1g/10mL, from the consumer level, due to the detection of microbial contamination. The contaminant identified in the product is Bacillus cereus, a type of bacteria that can potentially cause illness. The recall was announced and made public on September 22, 2023, highlighting the potential risk, especially to the immunocompromised population, posed by the contaminated product.
Sucralfate Oral Suspension is recognized as a therapeutic agent aimed at treating ulcers and is packed in a 16oz (414mL) PET Bottle, labeled with NDC 66689-305-16. The implicated lot, identified as number 810300, has an expiration date slated for October 31, 2023. The product, with its specific lot number and expiration date, has been distributed nationwide across various distributors via wholesale.
The risk associated with microbial contamination, particularly in immunocompromised individuals, is substantial, with the possibility of causing severe, life-threatening infections including endocarditis and necrotizing soft tissue infections. However, until the recall was announced, VistaPharm LLC has not been apprised of any adverse events or reports related to this specific recall.
To execute the recall efficiently, VistaPharm LLC has engaged a contractor, Inmar. Inmar is overseeing the recall process by notifying the distributors through recall packets, sent via FEDEX Next Day Delivery, supplemented by email notifications. It is also coordinating the return of all the recalled products. Distributors in possession of any remaining bottles from the affected Sucralfate Oral Suspension lot are instructed to return them to Inmar, following the provided instructions.
Consumers with queries or concerns regarding this recall have been directed to contact Inmar via email at [email protected] or its toll-free number on the company’s website. It is crucial for consumers who have experienced any issues possibly related to the consumption or use of this product to reach out to their healthcare providers or physicians immediately.
Further, any adverse reactions or quality issues encountered with the use of this product can be reported to the FDA’s MedWatch Adverse Event Reporting program, accessible online, through regular mail, or by fax. The recall, necessitated by the potential health risks due to microbial contamination, is being conducted with the full awareness and knowledge of the U.S. Food and Drug Administration.
This voluntary recall underscores the continuous commitment and responsibility of pharmaceutical companies like VistaPharm LLC to uphold stringent quality controls and prioritize consumer safety above all, ensuring swift and transparent actions to mitigate any potential risks to consumer health.
Have you or a loved one been impacted by the recent recall of Sucralfate Oral Suspension due to microbial contamination? Are you experiencing adverse effects or complications related to the consumption of a recalled product? Parker Waichman LLP, a national product injury law firm, is here to support and guide you during this challenging time.
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