Bracco Diagnostics multihance — Class III drug recall D-1663-2012
Terminated recall by Bracco Diagnostics Inc, reported 2012-09-05, distributed nationwide. Short Fill: The product is being recalled due to a potential underfill of the affected vials.
| Recall number | D-1663-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bracco Diagnostics Inc, Monroe Township, NJ, United States |
| Recall initiated | 2012-04-16 |
| Classified | 2012-08-27 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2013-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 47,750 vials |
| NDC | 00270-5164, 00270-5164-12, 00270-5164-13, 00270-5164-14, 00270-5164-15 |
| Lot numbers | 1P272A |
| Expiration dates | 2014-12-20 |
Product
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
Reason for recall
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
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-1663-2012. 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.