Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by...
FDA Recall #D-0220-2024 — Class I — November 17, 2023
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
Reason for Recall
Defective Container: powder may leak out of the pouch
Recalling Firm
InvaGen Pharmaceuticals, Inc. — Central Islip, NY
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
1240 boxes
Distribution
Nationwide within the United States
Code Information
Lot #: NB301030, Exp. Date 03/31/2025
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated