Cipla’s InvaGen Pharmaceuticals recalls Vigabatrin over seal integrity concerns

InvaGen Pharmaceuticals Inc., a wholly-owned subsidiary of Cipla Limited, has announced a voluntary recall of one lot of Vigabatrin for Oral Solution, USP 500mg, to the consumer level in the USA. This recall comes after the discovery of seal integrity issues in the product packaging, which could lead to powder leakage from the pouches.

The problem with the seal could result in the leakage of the powder blend, leading to a lower content of the medicine inside the pouch compared to the label claim. This poses a risk of potential underdosing, particularly concerning as the primary population at risk includes infants and young children. In such patients, inaccurate dosing could lead to serious adverse effects, such as intoxication or breakthrough seizures that might require medical intervention. To date, Cipla has not received any reports of adverse events related to this recall.

Vigabatrin for Oral Solution is used as adjunctive therapy in the treatment of Refractory Complex Partial Seizures in patients aged 2 years and older. It is not indicated as a first-line treatment but is used in patients who have responded adequately to several alternative treatments. The medication is packaged in foil pouches, each containing 500mg of Vigabatrin, with 50 foil sealed pouches in a shelf pack. The affected lot is NB301030, with an expiration date of 03/2025.

The recall encompasses the nationwide distribution of the product to partnered distributors and consignees. InvaGen Pharmaceuticals is conducting the recall with the knowledge of the U.S. Food and Drug Administration (FDA). They have taken steps to notify customers through various channels, including press releases, letters, telefax, telephone, email, and on-site visits, coordinating the return of all recalled products.

Distributors, retailers, and consumers in possession of the Vigabatrin for Oral Solution, USP 500mg Batch No. NB301030 are advised to initiate the return process through their respective places of purchase. This recall is a proactive measure by InvaGen Pharmaceuticals to ensure patient safety and uphold quality standards in the pharmaceutical industry.