The FDA is issuing an immediate recall of the anti-ulcer medication Sucralfate, with the cooperation of VistaPharm, LLC. Upon inspection, the ulcer prevention drug was contaminated with dangerous bacteria that may lead to serious health outcomes if ingested. As of the writing of this notice, no adverse effects have yet been reported.
SUMMARY
Date of Recall:
Announced: September 22, 2023
Public Notification: September 22, 2023
Name(s) of Drug:
Sucralfate Oral Suspension 1g/10mL
Company Name:
VistaPharm, LLC
Drug Indication:
Ulcer Prevention
Recall Product Description
Sucralfate is available by prescription only. The medication was distributed nationwide through major pharmacies and was packaged in dark bottles with white labels. Each label bears the medication name and dosage as well as the NDC number, lot number, and expiration date.
Reason for Recall
During inspection, it was found that the drug contained a dangerous bacterium, Bacillus cereus. As of the writing of this notice, no adverse events have yet been reported, but due to the health risk associated with Bacillus cereus, consumers must follow through with the recall if they possess the listed medication.
Impacts
Consumers who ingest the recalled medication may experience serious bacterial infections. Those with compromised immune systems are at the highest risk for complications.
Some consumers may experience a stomach illness (food poisoning) from the bacteria. With care, they may recover over a period of 24 hours. During that time, they will likely experience symptoms such as:
- Stomach Cramping
- Abdominal Pain
- Vomiting
- Diarrhea
- Nausea
However, if the bacteria enters a consumer’s bloodstream, they can experience severe and life-threatening illnesses such as:
- Endophthalmitis (eye infection)
- Bacteremia (blood infection)
- Cellulitis (skin infection)
- Brain Infection
- Endocarditis (heart infection)
- Osteomyelitis (bone infection)
- Pneumonia (lung infection)
- Meningitis (brain/spinal cord infection)
These serious illnesses each present with their own set of symptoms and must be treated immediately. If left unchecked, they can each lead to death.
Recall Lot Information
Consumers who use Sucralfate should locate their medication bottle and compare the numbers on the bottle to the chart below. If the numbers are a match, continue reading to find out how you can participate in the recall.
Product Description |
NDC |
Lot Number |
Expiration Date |
| Sucralfate Oral Suspension, 1g/10mL |
66689-305-16 |
810300 |
10/31/2023 |
Have you found that your medication is part of the recall? Here’s what you need to do:
Consumers
- Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any changes in your symptoms.
- Continue to monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
- Consumers may contact Inmar at 1-800-967-5952. They are available Mon-Fri from 9:00 a.m. to 5:00 p.m. (EST). You can also contact them via email at rxrecalls@Inmar.com.
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock affected by the recall immediately.
- Contact Inmar at 1-800-967-5952 or utilize rxrecalls@Inmar.com to contact them via email. Notify them of any recalled batches that have already been sold to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock affected by the recall immediately.
- Contact Inmar at 1-800-967-5952 or utilize rxrecalls@Inmar.com to contact them via email. Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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Sources:
https://my.clevelandclinic.org/health/diseases/23581-bacillus-cereus