Home / Recalls / InvaGen Pharmaceuticals, Inc. / D-0220-2024

D-0220-2024 Class I

Recalled by InvaGen Pharmaceuticals, Inc. — Central Islip, NY

FDA drug recall D-0220-2024 was initiated by InvaGen Pharmaceuticals, Inc. on Nov 17, 2023 and is designated Class I. Reason for recall: Defective Container: powder may leak out of the pouch Affected quantity: 1240 boxes.

Recall Details

Product Type: Drugs
Report Date: Jan 17, 2024
Initiation Date: Nov 17, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1240 boxes

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

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: NB301030, Exp. Date 03/31/2025

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0220-2024
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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