Recalling firm
InvaGen Pharmaceuticals, Inc.
Product type
Drug
Status
Completed
Report date
2024-01-17
Distribution
Nationwide within the United States
Firm state
NY
Product quantity
1240 boxes
Initiated by
Voluntary: Firm initiated
Reason for recall
Defective Container: powder may leak out of the pouch
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
Code / lot info
Lot #: NB301030, Exp. Date 03/31/2025
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.