# FDA recall D-157-2013

> **Bracco Diagnostic Inc** · Class I · drug recall initiated 2012-11-21.

## Product

Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany).

## Reason for recall

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-157-2013
- **Recalling firm:** Bracco Diagnostic Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-11-21
- **Report date:** 2013-02-13
- **Termination date:** 2015-07-06

- **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-157-2013

## Citation

> AI Analytics. FDA recall D-157-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-157-2013. Source: US FDA. Licensed CC0.

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