Multihance Multipack — Class II drug recall D-1665-2012
Terminated recall by Bracco Diagnostics Inc, reported 2012-09-05, distributed nationwide. Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product
| Recall number | D-1665-2012 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bracco Diagnostics Inc, Monroe Township, NJ, United States |
| Recall initiated | 2012-04-16 |
| Classified | 2012-08-28 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2013-11-13 |
| Distributed | Nationwide (US) |
| Quantity | 4,870 vials |
| Reason classes | sterility |
| NDC | 00270-5264, 00270-5264-16, 00270-5264-17 |
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 for recall
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1665-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.