Cytoprotective Agent
Where is Bleomycin made?
5 companies sell it under their own name. Their labels name 2 factories in the United States and India.
United States 1India 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC15 [USP'U], 30 [USP'U] · NDC 63323-136, 63323-137 | Fresenius Kabi USA, LLCMakes it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Hospira, Inc.15 [USP'U], 30 [USP'U] · NDC 61703-332, 0409-0332, 61703-323 +1 | Zydus Hospira Oncology Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJun 2023 |
| Hikma Pharmaceuticals USA Inc.15 [USP'U], 30 [USP'U] · NDC 0143-9240, 0143-9241 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Meitheal Pharmaceuticals Inc.15 [USP'U], 30 [USP'U] · NDC 71288-106, 71288-107 | The label doesn't name the factory. Plants this company names for other drugs | ||
| Northstar Rx LLC.15 [USP'U], 30 [USP'U] · NDC 16714-886, 16714-908 | The label doesn't name the factory. Plants this company names for other drugs | ||
Recalls
- Dec 21, 2023 · Class I · Pfizer
Presence of particulate matter: glass - Aug 5, 2021 · Class III · Hikma Pharmaceuticals USA Inc.
Labeling: Not elsewhere classified: Mislabeling
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.