Exact FDA event identifier

Event 66318

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

Open FDA event record

Event summary

Timeline bucket: September 17, 2013
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Amgen, 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

Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5.

D-66318-001

Recall number: D-66318-001
Initiated: September 17, 2013
Classification: Class II
Status: Terminated
Recalling firm: Amgen, Inc.
Quantity: 4,163 prefilled syringes

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: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.

Code information

Lot #: 1037592, Exp 07/15

Distribution pattern

Nationwide and Puerto Rico, Canada, Mexico, and clinical distribution in Europe.