Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| BIPSO GmbH | Singen (Hohentwiel), Germany | Makes it and tests it | Problems found, fixed voluntarilyMay 4, 2022 · 5 inspections |
| Bracco Imaging Spa | Ceriano Laghetto, Italy | Makes the active ingredient | Problems found, fixed voluntarilyOct 28, 2022 · 3 inspections |
| Patheon Italia S.p.A | Ferentino, Italy | Makes it and tests it | Problems found, fixed voluntarilyFeb 25, 2022 · 7 inspections, 1 with FDA action |
| BioChem Labor für biologische und chemische Analytik GmbH | Karlsruhe, Germany | Tests it | No problems foundMar 23, 2022 · 4 inspections |
| Labor LS SE & Co. KG | Bad Bocklet, Germany | Tests it | Problems found, fixed voluntarilyDec 14, 2022 · 6 inspections, 1 with FDA action |
Recalls
- Apr 16, 2012 · Class III · Bracco Diagnostics Inc
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Lots: Lot S1P272A Expiry Date: December 2014
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Gadolinium Cation (3+): every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 529 mg per 1 mL
- Approval
- NDA NDA021357
- On the market since
- Nov 23, 2004
- Package NDCs
0270-5164-120270-5164-130270-5164-140270-5164-15- Official label
- DailyMed (National Library of Medicine), updated Mar 14, 2025
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?