Elevated risk U.S. Food and Drug Administration

VistaPharm Sucralfate Oral Suspension 1g/10mL recall: Potential contamination with Bacillus cereus

Recall published 3+ years ago

Potential contamination with Bacillus cereus

VistaPharm Prescription & OTC drugs — recalled prescription & otc drugsVistaPharm Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Microbial contamination

This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

What the notice says: 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.

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
September 22, 2023
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
VistaPharm
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Sucralfate Oral Suspension 1g/10mL

What the company announced

FOR IMMEDIATE RELEASE – September 22, 2023 – Largo, Florida, 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.

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.

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.

A Contractor, Inmar, will perform this recall process, which is notifying its 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 to Inmar via instructions provided.

Consumers with questions regarding this recall can contact Inmar at 1-800-967-5952 or by email to [email protected] .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.

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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 1g/10mL
  • 810300

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • October 31, 2023

NDC number

On the carton and again on the bottle or blister label.

  • 66689-305-16

Package size

Match the net weight or the piece count on the front of the pack.

  • 10 mL
  • 16 oz
  • 414 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Contamination

VistaPharm — This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

  1. Stop eating it and keep it separate from other food.
  2. Read the official notice for the organism named — the advice for Listeria, Salmonella and hepatitis A is not the same.
  3. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.
  4. Bag and bin it, or return it to the store for a refund.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Potential contamination with Bacillus cereus — Consumers: Inmar, 1-800-967-5952, [email protected] — Media: Robin Fedina, 1-864-277-7282 x3541

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was VistaPharm prescription & otc drugs recalled?

Potential contamination with Bacillus cereus 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 1g/10mL, 810300; best-by date October 31, 2023. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it and keep it separate from other food.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

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