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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97110

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 21, 2025
Product types
Drug
Classifications
Class II
Statuses
Ongoing
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

3 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 3

PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21

D-0538-2025
Recall number
D-0538-2025
Initiated
April 21, 2025
Classification
Class II
Status
Ongoing
Quantity
6 Pre-filled syringes

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; potential temperature excursions due to transit delays

Code information

Lot: 1180924, Expiration date: 6/30/2027.

Distribution pattern

Within the U.S - OH, VA, FL.

drug · product 2 of 3

EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.

D-0539-2025
Recall number
D-0539-2025
Initiated
April 21, 2025
Classification
Class II
Status
Ongoing
Quantity
2 Pre-filled syringes

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; potential temperature excursions due to transit delays

Code information

Lot: 1178382, Expiration date: 3/31/2027

Distribution pattern

Within the U.S - OH, VA, FL.

drug · product 3 of 3

BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.

D-0540-2025
Recall number
D-0540-2025
Initiated
April 21, 2025
Classification
Class II
Status
Ongoing
Quantity
3 Vials

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; potential temperature excursions due to transit delays

Code information

Lot: YK4W, Expiration date: 4/30/2029

Distribution pattern

Within the U.S - OH, VA, FL.