FDA recall D-0220-2024

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

Reason for recall

Defective Container: powder may leak out of the pouch

Distribution

Nationwide within the United States

Key facts

Status

Completed

Initiation date

2023-11-17

Report date

2024-01-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Central Islip, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0220-2024