November 2023 FDA Recall Vigabatrin by Invagen Pharmaceuticals, Inc.
D-0220-2024 - Defective Container
This Class I drug recall was voluntarily initiated by Invagen Pharmaceuticals, Inc. on November 17, 2023 for the product Vigabatrin. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0220-2024
Defective Container: powder may leak out of the pouch
11-17-2023
01-17-2024
1240 boxes
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
InvaGen Pharmaceuticals, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
