FDA Drug recall D-157-2013
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-…
- FDA Drug
- Class I
- terminated
- Published 2013-02-13
On 2013-02-13 the FDA classified a Class I recall of 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-… by Bracco Diagnostic, citing presence of Particulate Matter; fibers identified as cellulose and polyvinyl.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-157-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-11-21 |
| Published | 2013-02-13 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bracco Diagnostic |
| Distribution | US |
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
Presence of Particulate Matter; fibers identified as cellulose and polyvinyl
Identifiers
| code_info | Lot #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-157-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.