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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77889

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

Open FDA event record

Event summary

Timeline bucket
August 04, 2017
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

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

Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subcutaneous Use Only, Rx only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799, Manufactured for: Janssen Products, LP Horsham, PA 19044, NDC 59676-340-01

D-1086-2017
Recall number
D-1086-2017
Initiated
August 04, 2017
Classification
Class II
Status
Terminated
Recalling firm
Amgen, Inc.
Quantity
175,632 vials

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 glass flakes identified as lamellae in some drug product vials.

Code information

Lot #: G290491A, G290491B, Exp. 06/18

Distribution pattern

United States including Puerto Rico