Last Updated on October 11, 2024 by The Health Master
Drug Recall
Drug Recall: In Largo, Florida, VistaPharm LLC is voluntarily recalling one (1) lot of Sucralfate Oral Suspension, 1 g/10 mL, 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 16-ounce (414-mL) 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 by its product name, Sucralfate Oral Suspension 1g per 10 mL, which is Lot No. 810300, with an expiration date of October 31, 2023, at the bottom right side of the label.
This sucralfate oral suspension lot was distributed nationwide to three (3) distributors by wholesale.
A contractor, Inmar, will perform this recall process, which involves notifying its distributors by recall packet delivered by FEDEX Next Day Delivery and receiving 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 the instructions provided.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).
Drug recall: WEFUN Capsules recalled due to presence of undeclared Sildenafil
Drug recall: Novartis recalled Cyclosporine oral solution
Drug recall: Digoxin Tablets recalled due to label mix-up
Drug recall: Glenmark recalls this High BP drug due to quality reasons
Drug recall: Alembic, Aurobindo recall these drugs for this reason
Drug recall: Lupin Pharma recalled these Birth Control Pills
Antimicrobial Resistance in India: The Alarming Rise and Potential Solutions –ICMR
Govt Job: CDSCO Recruitment 2023 – Lucrative Opportunity
Booming Growth in Indian Pharma Exports: August 2023 Report
Training of Technical Staff of Pharmaceutical Industry
USFDA issues Form 483 observations to Cipla’s Subsidiary
Boost for Medical Device Testing: CDSCO approves Nine New Laboratories
Quality Assurance Vs Quality Control in the Pharma Industry
CDSCO and Jharkhand Govt host 3-Day Training program for Drug Regulators
Drug alert: 48 out of 1166 samples declared as NSQ in August 2023
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: