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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62866

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

Open FDA event record

Event summary

Timeline bucket
June 01, 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

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

CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01

D-1684-2012
Recall number
D-1684-2012
Initiated
June 01, 2012
Classification
Class II
Status
Terminated
Recalling firm
Bracco Diagnostics Inc
Quantity
54 generators

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP deviation

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GMP deviation; Sr-82 levels exceeded alert limit specification

Code information

Lot numbers 09101-121251 and 09101-121391

Distribution pattern

Nationwide and United Kingdom