FDA Drug recall D-1665-2012
Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, R…
- FDA Drug
- Class II
- terminated
- Published 2012-09-05
On 2012-09-05 the FDA classified a Class II recall of Multihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, R… by Bracco Diagnostics, citing lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1665-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-04-16 |
| Published | 2012-09-05 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bracco Diagnostics |
| Distribution | US |
Product
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.
Reason
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Identifiers
| ndc | 0270-5264-16 |
|---|---|
| ndc | 0270-5264-17 |
| code_info | Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1665-2012%22
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