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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95830

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

Open FDA event record

Event summary

Timeline bucket
September 11, 2024
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mckesson Medical-Surgical Inc. Corporate Office

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

Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04

D-0116-2025
Recall number
D-0116-2025
Initiated
September 11, 2024
Classification
Class II
Status
Terminated
Quantity
5 cartons/20 units each carton

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: Temperature excursion

Code information

Serial # 100000831961 100000820688 100000820689 100000820515

Distribution pattern

Virgina