Isovue -300 — Class I drug recall D-158-2013
Terminated recall by Bracco Diagnostic Inc, reported 2013-02-13, distributed nationwide. Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
| Recall number | D-158-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bracco Diagnostic Inc, Monroe Township, NJ, United States |
| Recall initiated | 2012-11-21 |
| Classified | 2013-02-07 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2015-07-06 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00270-1315-67 |
| Lot numbers | 01/13, 03/13, 0A43282, 0C56283, 11/12, 9K34572 |
Product
Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67.
Reason for recall
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
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-158-2013. 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.