InvaGen Pharmaceuticals, a leading pharmaceutical company, has recently issued a voluntary recall of Vigabatrin for Oral Solution, USP 500mg nationwide. The recall was initiated due to concerns over leaking sachets, which could potentially compromise the integrity and effectiveness of the medication. The U.S. Food and Drug Administration (FDA) has also issued an alert to inform healthcare professionals and patients about this recall.
Vigabatrin is an antiepileptic drug used to treat complex partial seizures in adults and children. It works by reducing abnormal electrical activity in the brain. The oral solution form of Vigabatrin is commonly prescribed to patients who have difficulty swallowing tablets or capsules.
The recall was initiated after InvaGen Pharmaceuticals received several complaints from customers regarding leaking sachets. Leaking sachets can lead to a loss of medication, making it difficult for patients to receive the full prescribed dose. Additionally, the leakage can compromise the sterility of the product, potentially leading to contamination and adverse effects.
The FDA has classified this recall as a Class II recall, which means that the use of the affected product may cause temporary or medically reversible adverse health consequences. However, the likelihood of serious harm is relatively low.
InvaGen Pharmaceuticals is working closely with the FDA to investigate the root cause of the issue and implement corrective actions to prevent similar incidents in the future. The company has also notified its distributors and customers about the recall and is arranging for the return of all affected products.
Healthcare professionals are advised to immediately discontinue the use and distribution of the affected product and quarantine any remaining inventory. Patients who have been prescribed Vigabatrin for Oral Solution, USP 500mg should contact their healthcare provider to discuss alternative treatment options.
It is important for patients not to abruptly stop taking Vigabatrin without consulting their healthcare provider, as sudden discontinuation can lead to an increase in seizure frequency. Healthcare professionals will work with patients to find suitable alternatives and ensure a smooth transition.
The FDA encourages healthcare professionals and patients to report any adverse events or quality problems related to the use of Vigabatrin for Oral Solution, USP 500mg or any other medication to the FDA’s MedWatch Adverse Event Reporting program. This allows the FDA to monitor the safety and quality of medications and take appropriate actions to protect public health.
In conclusion, InvaGen Pharmaceuticals has voluntarily recalled Vigabatrin for Oral Solution, USP 500mg nationwide due to leaking sachets. The FDA has issued an alert to inform healthcare professionals and patients about this recall. Patients who have been prescribed this medication should contact their healthcare provider to discuss alternative treatment options. It is crucial to report any adverse events or quality problems to the FDA to ensure the safety and effectiveness of medications.
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