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  3. Recall Enforcement Event ID: 97110

Recall Enforment Report D-0540-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Mckesson Medical-Surgical Inc. Corporate Office, originally initiated on 04-21-2025 for the product BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK. The product was recalled due to cgmp deviations; potential temperature excursions due to transit delays. The product was distributed in Within The U.s - Oh, Va, Fl. and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0540-202504-21-202507-30-2025Class II3 VialsBENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.CGMP Deviations; potential temperature excursions due to transit delaysOngoing
D-0539-202504-21-202507-30-2025Class II2 Pre-filled syringesEVENITY, (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.CGMP Deviations; potential temperature excursions due to transit delaysOngoing
D-0538-202504-21-202507-30-2025Class II6 Pre-filled syringesPROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21CGMP Deviations; potential temperature excursions due to transit delaysOngoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
49401-088Benlysta BelimumabSolutionSubcutaneousGlaxosmithkline LlcHuman Prescription Drug
49401-101Benlysta BelimumabInjection, Powder, Lyophilized, For SolutionIntravenousGlaxosmithkline LlcHuman Prescription Drug
49401-102Benlysta BelimumabInjection, Powder, Lyophilized, For SolutionIntravenousGlaxosmithkline LlcHuman Prescription Drug
55513-710Prolia DenosumabInjectionSubcutaneousAmgen, IncHuman Prescription Drug
55513-880Evenity Romosozumab-aqqgInjection, SolutionSubcutaneousAmgen IncHuman Prescription Drug
55513-998Evenity Romosozumab-aqqgInjection, SolutionSubcutaneousAmgen IncHuman Prescription Drug