CLASS III Drug recall · Reported 5 Sep 2012 · FDA Enforcement Report
multihance (gadobenate dimeglumine) injection, 529 mg/mL recalled
Bracco Diagnostics is recalling multihance (gadobenate dimeglumine) injection, 529 mg/mL, distributed nationwide in the US. The recall was initiated on 16 Apr 2012 and the FDA has classified it as Class III.
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-1663-2012
- FDA event ID
- 62636
- Recalling firm
- Bracco Diagnostics, Monroe Township, NJ
- Brand
- Multihance
- Manufacturer
- BRACCO DIAGNOSTICS INC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Apr 2012
- FDA classified
- 27 Aug 2012
- Reported
- 5 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 16 Apr 2012 | Recall initiated by company | |
| 27 Aug 2012 | Classified by FDA | +133 days |
| 5 Sep 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
Which lots are affected?
Lot S1P272A Expiry Date: December 2014
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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
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|---|---|---|---|---|---|
| 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 II | Multihance Multipack (gadobenate dimeglumine) injection recalledMultihance | Bracco Diagnostics | Sterility | Nationwide |