Vigabatrin recall issued due to leaking sachets

Vigabatrin recall overview: 

• Who: Invagen Pharmaceuticals voluntarily recalled one lot of Vigabatrin for Oral Solution, USP 500 milligrams.
• Why: The company initiated the recall over concerns the drug’s packaging has a seal integrity issue that allows for powder to leak, leading to an incorrectly administered dosage. 
• Where: The recall affects consumers nationwide. 

Invagen Pharmaceuticals issued a voluntary nationwide recall for one lot of Vigabatrin for Oral Solution, USP 500 milligrams, over concerns the seals on their packaging have an integrity issue that allows powder to leak from their pouches. 

The recall, which the U.S. Food and Drug Administration (FDA) published Dec. 11, involves Vigabatrin for Oral Solution, USP 500 milligrams, packaged in foil pouches with batch No. NB301030 and an expiration date of March 2025. 

Vigabatrin is an oral solution used to treat refractory complex partial seizures as an adjunctive therapy for patients ages 2 and older who have responded adequately to several alternative treatments, according to the Vigabatrin recall. 

Cipla Limited, the parent company of Invagen Pharmaceuticals, says it is concerned a leakage could lead to inaccurate dosing, which can cause serious adverse health effects such as intoxication or breakthrough seizures requiring medical intervention.

“For a small minority of patients, who might have severe or repeated breakthrough seizures, a drop in their phenytoin blood levels could result in life-threatening seizures requiring immediate emergency room treatment,” the Vigabatrin recall states. 

Infants, young children most at risk for adverse health events, Vigabatrin recall says

Patients most at risk of developing serious adverse health effects in connection with the recall are infants and young children, according to the FDA’s announcement. 

Cipla says it is coordinating the return of all the recalled Vigabatrin and notifying its customers through press releases, letters, telefax, telephone, email and on-site visits. 

The pharmaceutical company says it has not received any reports of adverse events connected to the Vigabatrin recall. 

Individuals with more questions about the recall can contact Cipla directly at 844-247-5287 or via email. 

In another recall involving an oral solution, Novartis initiated a recall for two lots of its Sandimmune oral solution 100 milligrams/milliliter earlier this month after the company found a crystal formation in some of the bottles. 

Are you affected by the Vigabatrin recall? Let us know in the comments.

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