Cipla Limited’s subsidiary InvaGen Pharmaceuticals recalls Vigabatrin Oral Solution

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In an important safety announcement, Cipla Limited revealed that its wholly-owned subsidiary, InvaGen Pharmaceuticals Inc., based in the USA, is conducting a voluntary recall of a specific lot of Vigabatrin for Oral Solution, USP 500mg. This decision to recall was made due to the discovery of seal integrity issues, which have led to the leakage of powder from the pouches.

Details of the Recalled Product

The product in question is Vigabatrin for Oral Solution, USP 500mg/sachet, identified by the Batch No. NB301030 with an expiration date of March 2025 (NDC# 6909-7964-53). Concerns arose when it was noted that the improper seal in the pouches could lead to powder leakage, resulting in a lower content of the medicine inside the pouch than what is stated on the label. This discrepancy could potentially cause underdosing, posing serious risks, particularly to infants and young children.

Safety Concern Leads to Vigabatrin Recall by InvaGen Pharmaceuticals, a Cipla Subsidiary

Safety Concern Leads to Vigabatrin Recall by InvaGen Pharmaceuticals, a Cipla Subsidiary

Health Risks and Implications

For patients relying on this medication, especially young ones, inaccurate dosing could lead to serious adverse effects such as intoxication or breakthrough seizures necessitating medical intervention. In some severe cases, reduced phenytoin levels could lead to life-threatening seizures, making immediate emergency room treatment crucial.

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Distribution and Recall Details

Vigabatrin for Oral Solution is primarily used for treating Refractory Complex Partial Seizures as an adjunctive therapy in patients aged 2 years and older. It is not indicated as a first-line agent. Each package of the recalled product contains 50 foil sealed pouches, each with 500mg of Vigabatrin. The affected lot was distributed nationwide to various distributors and consignees.

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Recall Procedure and Consumer Advisory

InvaGen Pharmaceuticals is actively notifying customers through various channels, including press releases, letters, telefax, telephone, email, and on-site visits. The company is coordinating the return of all recalled products. Distributors, retailers, and consumers in possession of the affected Vigabatrin batch are advised to initiate the return process through their respective places of purchase. This recall is being conducted with the full knowledge and cooperation of the U.S. Food and Drug Administration.

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Cipla and InvaGen’s Commitment to Safety

Cipla has stated that no adverse events related to this recall have been reported so far. The company’s commitment to patient safety remains paramount, as evidenced by their proactive measures in addressing this issue. Consumers and healthcare providers are encouraged to report any adverse reactions or quality issues to the FDA’s MedWatch Adverse Event Reporting program.

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