Recall: D-0220-2024

Class I - Dangerous

Class IClassification

2023-11-17Initiated

CompletedStatus

InvaGen Pharmaceuticals, Inc.Firm

Product

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

Defective Container: powder may leak out of the pouch

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.