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Peru’s Digemid Recalls AZAGLOB Azathioprine Lot After Failed Content Test

The finding points to subpotent tablets that could derail transplant and autoimmune care.

Overview

  • Digemid, which issued Sanitary Alert No. 046-2026 on Thursday, ordered the withdrawal and destruction of AZAGLOB 50 mg lot 25GT0891 sold in boxes of 100 tablets.
  • Quality control showed the lot failed the azathioprine content assay, meaning some tablets may not contain the labeled dose.
  • Patients who have boxes from this lot should stop using them and contact Digemid or their clinician for guidance as the recall proceeds.
  • The product was manufactured by Globela Pharma in India, and the Peruvian marketing authorization is held by Droguería Perú S.A.C., reflecting cross-border production with local oversight.
  • Azathioprine is an immunosuppressant used to prevent organ rejection and to treat diseases like lupus and rheumatoid arthritis, so under-dosing can trigger rejection or flare-ups.