Exact FDA event identifier

Event 62735

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: April 16, 2012
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Bracco Diagnostics 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 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 1

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.

D-1665-2012

Recall number: D-1665-2012
Initiated: April 16, 2012
Classification: Class II
Status: Terminated
Recalling firm: Bracco Diagnostics Inc
Quantity: 4,870 Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.

Code information

Lot #: a) 9J37457, 9J44058, Exp 10/12; b) 9I28973, Exp 09/12

Distribution pattern

Nationwide