CLASS II Drug recall · Reported 5 Sep 2012 · FDA Enforcement Report
Multihance Multipack (gadobenate dimeglumine) injection recalled
Bracco Diagnostics is recalling Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy - Not for, distributed nationwide in the US. The recall was initiated on 16 Apr 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1665-2012
- FDA event ID
- 62735
- Recalling firm
- Bracco Diagnostics, Monroe Township, NJ
- Brand
- Multihance
- Manufacturer
- BRACCO DIAGNOSTICS INC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 16 Apr 2012
- FDA classified
- 28 Aug 2012
- Reported
- 5 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Apr 2012 | Recall initiated by company | |
| 28 Aug 2012 | Classified by FDA | +134 days |
| 5 Sep 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Which lots are affected?
Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bracco Diagnostics
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | E-Z-Paste Barium Sulfate Esophageal Cream (60% w/w) tube recalledE-z-paste | Bracco Diagnostics | Potency & Assay | Nationwide |
| Drug | CLASS III | VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w) recalled | Bracco Diagnostics | Potency & Assay | Nationwide |
| Drug | CLASS III | Tagitol V Barium Sulfate Suspension (40% w/v recalled | Bracco Diagnostics | Potency & Assay | Nationwide |
| Drug | CLASS II | Gastrografin (Diatrizoate Meglumine recalled by Bracco DiagnosticsGastrografin | Bracco Diagnostics | Particulate Matter | Nationwide |
| Drug | CLASS II | Cardiogen-82 (Rubidium Rb 82 Generator), 140 millicurie recalledCardiogen-82 | Bracco Diagnostics | Processing Deviation | Nationwide |
Other Gadobenate Dimeglumine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | multihance (gadobenate dimeglumine) injection, 529 mg/mL recalledMultihance | Bracco Diagnostics | Packaging Defects | Nationwide |