FDA-Drug2024-01-17Class I

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

InvaGen Pharmaceuticals, Inc.
Hazard

Defective Container: powder may leak out of the pouch

Sold states
Nationwide within the United States
Affected count
1240 boxes
Manufactured in
550 S Research Pl, Central Islip, NY, United States
Products
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

Official notice

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

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