Product Safety Recalls

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VIGABATRIN Recall D-0220-2024

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

VIGABATRIN Recall D-0220-2024 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0220-2024
Event ID93422
Original Package?1
Active SubstanceVIGABATRIN
Drug RouteORAL
DistributionNationwide within the United States
Quantity1240 boxes
Recall ReasonDefective Container: powder may leak out of the pouch
Drug ClassificationClass I
Drug Code Info20240117
Product NDC69097-964
Product NUIN0000175753
Pharma Class (EPC)Anti-epileptic Agent [EPC]
Recall Initiation Date20231117
Report Date20240117
Classification Date20240108
Address550 S Research Pl
Central Islip, NY 11722-4415
United States
Recalling FirmInvaGen Pharmaceuticals, Inc.
Initial Notification Letter
Unique Ingredient IdentifierGR120KRT6K
Drug Application NumberANDA211592
Structured Product Labeling (SPL ID)4cdad60f-7614-47cb-8594-3c0257e55c28
Structured Product Labeling (SPL Set ID)823cc915-0350-4780-85ed-cd1c338e429d
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