NDC 0270-0083
Choletec 45 mg injection, powder, lyophilized, for solution
On the label: Bracco Diagnostics Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Jubilant HollisterStier LLC | Spokane, WA, United States | Makes it and tests it | No problems foundMar 5, 2021 · 13 inspections, 1 with FDA action |
| Sigma-Aldrich Production GmbH | Buchs, Switzerland | Makes the active ingredient | No problems foundSep 22, 2023 · 3 inspections |
| Eurofins Lancaster Laboratories, LLC | Lancaster, PA, United States | Tests it | Problems found, fixed voluntarilyAug 26, 2025 · 8 inspections |
| GE Healthcare Inc. (Medi-Physics, Inc. dba GE Healthcare) | Arlington Heights, IL, United States | Tests it | No problems foundSep 19, 2025 · 8 inspections |
| SGS North America Inc. | Lincolnshire, IL, United States | Tests it | Problems found, fixed voluntarilyMar 20, 2026 · 9 inspections |
Recalls
- Aug 14, 2012 · Class III · Bracco Diagnostic Inc
Presence of Particulate Matter; potential for charcoal particulates
Lots: Lot #s: C0672, Exp 09/30/2012; C0689, Exp 10/31/2012; C0723, Exp 12/31/2012; C0799, Exp 02/28/2013; C0852, Exp 05/31/2013.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Mebrofenin: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 45 mg
- Approval
- NDA NDA018963
- On the market since
- Jan 21, 1987
- Package NDCs
0270-0083-20- Official label
- DailyMed (National Library of Medicine), updated Nov 29, 2025
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