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Honored Contributor
Posts: 13,510
Registered: ‎05-23-2010

Recall of Sucralfate Oral Suspension due to possible microbial contamination with B cereus bacteria

[ Edited ]

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/vistapharm-llc-issues-voluntary-...

 

This recall is due to possible contamination with B cereus bacteria. 

"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."Quoted from FDA website page.



"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." Quoted from FDA website page. 



"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. To date, VistaPharm LLC has not received any reports of adverse events related to this recall." Quoted from the FDA website for this recall. 


Note from me:  ENDOCARDITIS is an inflammation of the inner layer of the heart. NECROTIZING 
SOFT TISSUE INFECTIONS are what's commonly called flesh eating bacteria. It can also lead to vision loss. B cereus can also lead to respiratory infections and abdominal illnesses. 

 

 

 

This medicine is used for stomach illnesses such as ulcers and stomach inflammation. 
The oral suspension (liquid) IMG_3210.pngIt is often not used just for ulcers, depending on the doctor and hospital prescribing it to patients. 

 

 

 

OK, this one almost gave me a heart attack. 

My husband is currently on sucralfate and I got a fright when I first saw this. Fortunately, he is on the pill form of this medicine. 

Respected Contributor
Posts: 4,692
Registered: ‎03-15-2021

Re: Recall of Sucralfate oral suspension due to possible microbial contamination with B cereus bacte

When my acid was completely out of control I was given this liquid. That was a couple of years ago, but I could not tolerate it.

 

Thank you for making us aware. I am glad I am no longer needing it.

Respected Contributor
Posts: 4,692
Registered: ‎03-15-2021

Re: Recall of Sucralfate oral suspension due to possible microbial contamination with B cereus bacte

@Mindy D I see your photo posted successfully. That is good news.

Honored Contributor
Posts: 13,510
Registered: ‎05-23-2010

Re: Recall of Sucralfate oral suspension due to possible microbial contamination with B cereus bacte


@On It wrote:

@Mindy D I see your photo posted successfully. That is good news.


@On It I can post photos that are lower in pixelation or are embedded in some text but not other texts. The photos on the FDA website are lower file sizes, so they post. 

Esteemed Contributor
Posts: 5,666
Registered: ‎09-08-2010

Re: Recall of Sucralfate Oral Suspension due to possible microbial contamination with B cereus bacte

Thank you for posting this. I was just prescribed this medication (different mfr.), last week. Luckily mine isn't the same. I prefer the liquid over the pills.