Exact FDA event identifier

Event 62636

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

Event summary

Timeline bucket: April 16, 2012
Product types: Drug
Classifications: Class III
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

Bracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15

D-1663-2012

Recall number: D-1663-2012
Initiated: April 16, 2012
Classification: Class III
Status: Terminated
Recalling firm: Bracco Diagnostics Inc
Quantity: 47,750 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Short Fill: The product is being recalled due to a potential underfill of the affected vials.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Short Fill: The product is being recalled due to a potential underfill of the affected vials.

Code information

Lot S1P272A Expiry Date: December 2014

Distribution pattern

Nationwide