Exact FDA event identifier

Event 85938

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

Event summary

Timeline bucket: June 29, 2020
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: EMD Serono, 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

Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD 02370, NDC: 44087-1225-1

D-1379-2020

Recall number: D-1379-2020
Initiated: June 29, 2020
Classification: Class II
Status: Terminated
Recalling firm: EMD Serono, Inc.
Quantity: 30,756 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.

Code information

Lot # 8J025A; 8J025B, Exp 09/30/2020

Distribution pattern

Nationwide in the US