Bracco Diagnostics Inc
Name in FDA records: BRACCO DIAGNOSTICS INC
NDC labeler code: 0270
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- IopamidolIsovue-M, Isovue 370, Isovue 300 · 8 products
- GadopiclenolElucirem, Vueway · 5 products
- Sulfur hexafluorideLumason · 2 products
- GadoteridolProhance · 2 products
- Diatrizoate meglumineCystografin, Cystografin Dilute · 2 products
- Gadobenate dimeglumineMultihance · 2 products
- Iomeprol injectionIomervu · 2 products
- Rubidium chloride RB-82Cardiogen-82, Ruby-Fill · 1 product
- SincalideKinevac · 1 product
- Kit for the preparation of technetium tc 99M mebrofeninCholetec · 1 product
- Diatrizoate meglumine and diatrizoate sodiumMd Gastroview, Gastrografin · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| November 27, 2024 | NDA216016 | Iomeprol injection IOMERVU | Bracco |
| September 21, 2022 | NDA216986 | Gadopiclenol ELUCIREM | Guerbet |
| October 10, 2014 | NDA203684 | Sulfur hexafluoride LUMASON | Bracco |
| November 23, 2004 | NDA021357 | Gadobenate dimeglumine MULTIHANCE | Bracco |
| November 23, 2004 | NDA021358 | Gadobenate dimeglumine MULTIHANCE MULTIPACK | Bracco |
| October 9, 2003 | NDA021489 | Gadoteridol PROHANCE MULTIPACK | Bracco |
| October 12, 1994 | NDA020327 | Iopamidol ISOVUE-200, ISOVUE-250, ISOVUE-300 | Bracco |
| November 16, 1992 | NDA020131 | Gadoteridol PROHANCE | Bracco |
| December 29, 1989 | NDA019414 | Rubidium chloride RB-82 CARDIOGEN-82 | Bracco |
| January 21, 1987 | NDA018963 | Kit for the preparation of technetium tc 99M mebrofenin CHOLETEC | Bracco |
| December 31, 1985 | NDA018735 | Iopamidol ISOVUE-128, ISOVUE-200, ISOVUE-250 | Bracco |
| July 21, 1976 | NDA017697 | Sincalide KINEVAC | Bracco |
| January 17, 1958 | NDA011245 | Diatrizoate meglumine and diatrizoate sodium GASTROGRAFIN | Bracco |
| August 2, 1955 | NDA010040 | Diatrizoate meglumine CYSTOGRAFIN, CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE | Bracco |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2022
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April 13, 2022 · Class II · Terminated · D-1087-2022 · Sincalide
cGMP deviations: Temperature abuse
Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0556-15
-
April 13, 2022 · Class II · Terminated · D-1086-2022 · Diatrizoate meglumine and diatrizoate sodium
cGMP deviations: Temperature abuse
Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), packaged in: Twenty-four 30 mL single dose bottles, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0445-35
2013
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June 21, 2013 · Class II · Terminated · D-885-2013 · Diatrizoate meglumine and diatrizoate sodium
Presence of foreign substance: One lot of the product may contain black foreign particles
Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution), USP, 37% Organically Bound Iodine, 120 ml bottle, Rx only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543 by Therapex, Division of E-Z-E
2012
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November 21, 2012 · Class I · Terminated · D-157-2013 · Iopamidol
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Pr
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November 21, 2012 · Class I · Terminated · D-158-2013 · Iopamidol
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67.
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August 14, 2012 · Class III · Terminated · D-095-2013 · Kit for the preparation of technetium tc 99M mebrofenin
Presence of Particulate Matter; potential for charcoal particulates
Choletec - Kit for the Preparation of Technetium Tc 99m Mebrofenin, 10 vials per box, Nonradioactive, Diagnostic Use, For Intravenous Use, Multidose, Rx Only, Manufactured for Bracco Diagnostics Inc. Princeton, NJ 08543,
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June 1, 2012 · Class II · Terminated · D-1684-2012 · Rubidium chloride RB-82
GMP deviation; Sr-82 levels exceeded alert limit specification
CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Pla
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April 16, 2012 · Class III · Terminated · D-1663-2012 · Gadobenate dimeglumine
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15
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April 16, 2012 · Class II · Terminated · D-1665-2012 · Gadobenate dimeglumine
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for:
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
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Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026