Vigabatrin Powder, For Solution
FDA Recall NDC 69097-964
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Vigabatrin (NDC 69097-964). A significant event, classified as Class I, was initiated on Nov 17, 2023 by Cipla Usa, Inc.. The reported reason for this action was: "Defective Container: powder may leak out of the pouch"
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Completed
Defective Container: powder may leak out of the pouch
Nov 17, 2023
Jan 17, 2024
1240 boxes
Recall Profile & Regulatory Data
Event ID
93422
Classification
Class I
Enforcement Status
Completed
Recalling Firm
InvaGen Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Product Description
Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53
Batch or Lot Expiration Information
Lot# : NB301030, Exp. Date 03/31/2025
Affected Packages Involved in this Recall
69097-964-53Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
