Five medicine-safety updates — 22 September 2026

Five new official materials cover two critical US injectable-drug recalls, an Australian regulatory action on Andrographis, and two Ukraine SEC updates.

1. Sodium chloride / concentrated potassium mix-up

FDA published a recall of 0.9% Sodium Chloride Injection, USP, 100 ml, lot 1042188: an overwrap may contain Potassium Chloride Injection 10 mEq, lot 1035181. Inadvertent administration can cause dysrhythmias and fatal cardiac arrest. No related adverse events had been reported. Official FDA material.

2. Dexmedetomidine particulates

Par Health is recalling Dexmedetomidine HCl in 0.9% Sodium Chloride Injection lots 87558 and 88802 because cellulose or stopper-material particles can cause life-threatening emboli, vascular occlusion and phlebitis with clotting. Official FDA material.

3. Andrographis removed from the Australian listed-medicines framework

TGA determined that severe allergic reactions, including anaphylaxis, cannot be adequately managed under the lower-risk pathway. New listed medicines containing Andrographis are no longer eligible; sponsors of existing products are urged to cancel or recall as appropriate. Reports include a fatal case. Official TGA material.

4. Cabazitaxel Accord dilution errors

The 20 mg/ml product requires one-step dilution, whereas the 60 mg/1.5 ml presentation requires two steps and is 10 mg/ml before final dilution. Confusion can cause potentially fatal overdose or underdosing. Official Ukraine SEC material.

5. Laronidase (Aldurazyme) and breastfeeding

Following PASS review, evidence on excretion into human milk remains insufficient. Breastfeeding decisions should balance benefits for mother and child against the potential risk to the infant. Official Ukraine SEC material.

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on official communications issued by FDA, TGA and the State Expert Center of the Ministry of Health of Ukraine (Ukraine SEC) on 21 September 2026. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by any manufacturer/marketing authorisation holder or a quality concern affecting a company’s entire product portfolio. Company and product names are used only to identify the official materials accurately. Decisions should be based on the primary sources, the regulators’ instructions and the approved product information.