U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Safety
  3. Recalls, Market Withdrawals, & Safety Alerts
  4. InvaGen Pharmaceuticals Issues Voluntary Nationwide Recall of Vigabatrin for Oral Solution, USP 500mg Due to Leaking Sachets
  1. Recalls, Market Withdrawals, & Safety Alerts

COMPANY ANNOUNCEMENT

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

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

Read Announcement

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Due to seal integrity issues allowing for powder leakage from the pouch.
Company Name:
InvaGen Pharmaceuticals Inc.
Brand Name:
Brand Name(s)
No Brand
Product Description:
Product Description
Vigabatrin for Oral Solution, USP 500mg

Company Announcement

REVISED PRESS RELEASE: NOTE: This press release is a revision to the one posted on December 09, 2023. This has been revised in accordance with FDAs request to remove specific risk assessment information which was not pertinent to this product.

December 15, 2023 – Hauppauge, NY, 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.

Sr. No. Product Name NDC# Batch No. Expiry Date
1. 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. The population at risk is primarily infants and young children. In those patients, there is a reasonable probability that inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention. Cipla has not received any reports of adverse events related to this recall.

The product is used for the treatment of Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded adequately to several alternative treatments. Vigabatrin for oral solution is not indicated as a first-line agent. The medication is packaged in foil pouches, each containing 500mg of Vigabatrin, and there are 50 foil sealed pouches in a shelf pack. The affected lot is NB301030, with an expiration date of 03/2025. The Vigabatrin for Oral Solution, USP 500mg product was distributed nationwide to partnered distributors and consignees.

InvaGen Pharmaceuticals is notifying the customer level through press releases, letters, telefax, telephone, email, and on-site visits, and is coordinating the return of all recalled products. Distributors, retailers and consumers in possession of Vigabatrin for Oral Solution, USP 500mg Batch No. NB301030, NDC# 6909-7964-53 are advised to initiate the return process through their respective place of purchase.

Consumers with questions regarding this recall can contact Cipla by phone number 844- CIPLAUS (844-247-5287) M-F 8:30 AM-5:00 PM EST, or email cipla.cs@cipla.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this batch of drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

DISCLAIMER
Cipla maintains stringent quality processes to assess quality defects and safety issues. Cipla conducts regular investigation and assessment by committees consisting of subject-matter experts, quality management, and medical safety experts.

For queries, please contact:

Corporate Communications
Heena Kanal
E-Mail: CorpComm@cipla.com

Company Contact Information

Consumers:
Cipla
844-247-5287
cipla.cs@cipla.com
Media:
Heena Kanal
+91 22 24826000
Back to Top