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InvaGen Pharmaceuticals Issues Voluntary Nationwide Recall of Vigabatrin for Oral Solution, USP 500mg due to Leaking Sachets

Dec 11, 2023

Cipla Limited today announced that its wholly-owned subsidiary, InvaGen Pharmaceuticals Inc. is voluntarily recalling one lot of Vigabatrin for Oral Solution, USP 500mg, to the consumer level. Vigabatrin for Oral Solution, USP 500 mg has been found to have seal integrity issues allowing for powder leakage from the pouch.


Product Name                                                                          NDC#                   Batch No.      Expiry Date

Vigabatrin for Oral Solution, USP 500mg/sachet    6909-7964-53  NB301030    03/2025


An improper seal in the pouch may lead to the leakage of powder blend outside the pouch, resulting in a lower content of medicine inside the pouch compared to the label claim and result in potential underdosing.

FDA Notice WCTU Cleveland 13 News Notice Graphic.jpg
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