# FDA recall D-1665-2012

> **Bracco Diagnostics Inc** · Class II · drug recall initiated 2012-04-16.

## 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.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1665-2012
- **Recalling firm:** Bracco Diagnostics Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-04-16
- **Report date:** 2012-09-05
- **Termination date:** 2013-11-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Monroe Township, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1665-2012

## Citation

> AI Analytics. FDA recall D-1665-2012. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1665-2012. Source: US FDA. Licensed CC0.

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