D-0220-2024 Class I
FDA drug recall D-0220-2024 was initiated by InvaGen Pharmaceuticals, Inc. on November 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
- January 17, 2024
- Initiation Date
- November 17, 2023
- Termination Date
- N/A
- 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