InvaGen Pharmaceuticals, Inc. recalls Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceutic…
- Recall date
- November 17, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0220-2024
- FDA classification
- Class I
- Brand / firm
- InvaGen Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide within the United States
Why it was recalled
Defective Container: powder may leak out of the pouch
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
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
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