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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63765

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 21, 2012
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Bracco Diagnostic Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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).

D-157-2013
Recall number
D-157-2013
Initiated
November 21, 2012
Classification
Class I
Status
Terminated
Recalling firm
Bracco Diagnostic Inc
Quantity
5483 syringes (548.3 boxes)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

Code information

Lot #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13

Distribution pattern

Nationwide.

drug · product 2 of 2

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.

D-158-2013
Recall number
D-158-2013
Initiated
November 21, 2012
Classification
Class I
Status
Terminated
Recalling firm
Bracco Diagnostic Inc
Quantity
5736 syringes (573.6 boxes)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

Code information

Lot #: 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13

Distribution pattern

Nationwide.