Immediate Recall of Anti-Ulcer Medication Issued - MedWaste Management Immediate Recall of Anti-Ulcer Medication Issued - MedWaste Management

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Recall Sucralfate Oral Suspension Med Waste Management

Immediate Recall of Anti-Ulcer Medication Issued

 

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 Sucralfate Oral Suspension Bottle

Recall Sucralfate Oral Suspension Label

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

FDA.gov

 

Have you found that your medication is part of the recall? Here’s what you need to do:

 

Consumers

  1. Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any changes in your symptoms.
  2. Continue to monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
  3. 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.
  4. 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.
  5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

 

Retailer

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. 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.
  3. Notify affected consumers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

 

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. 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.
  3. Notify affected retailers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

 

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Established in 2008, MedWaste Management fills a need for compliant and safe medical waste disposal to the healthcare industry and the general public alike. We publish this blog to spread useful and practical information to help you stay safe, smart, and healthy!

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Tammy McKinney, Nurse Writer

 

Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or reach out to her directly on LinkedIn!

 

Sources:

www.fda.gov

https://my.clevelandclinic.org/health/diseases/23581-bacillus-cereus

 

 

One response

  1. Itzel Kerr Avatar

    I just like the helpful information you provide in your articles


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