Status
Completed
Drug Enforcement D-0220-2024
Defective Container: powder may leak out of the pouch
Classification
Class I
Report Date
January 17, 2024
Termination Date
—
Product Information
- 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
- Product quantity
- 1240 boxes
- Reason for recall
- Defective Container: powder may leak out of the pouch
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- InvaGen Pharmaceuticals, Inc.
- Address
-
550 S Research Pl
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0220-2024
- Event ID
- 93422
- Recall initiation date
- November 17, 2023
- Center classification date
- January 8, 2024
- Code info
- Lot #: NB301030, Exp. Date 03/31/2025
- More code info
- —