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Recall Observatory FDA recall evidence

Drug product

Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.

D-0561-2025

July 18, 2025

Class II

Product summary

Firm
AEQUITA PHARMACY
Event
Event 97292
Status
Ongoing
Classification
Class II
Quantity
221 vials
Official record key
drug-enforcement:D-0561-2025

Official wording

Reason: Lack of Processing Controls.

Code information: All Lots within expiry.

Distribution pattern: MA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    Lack of Processing Controls