Corrective medicine safety update: B. Braun, Baxter and Tecfidera

Corrective regulatory safety update — 1 September 2026. This consolidated notice addresses three previously identified materials that had not been presented in full. The EMA PRAC agenda is included separately as an administrative pharmacovigilance note.

B. Braun: 0.9% Sodium Chloride Injection recall update

The FDA update concerns 0.9% Sodium Chloride Injection USP in 100 mL and 150 mL PAB containers, lots J6B435, J6B444 and J6B457. The recall reason was updated on 28 August 2026 to identify iron oxide particles. Administration of particulate-contaminated intravenous product may lead to embolic events, vascular occlusion, organ damage or haemolysis. Healthcare facilities should follow the manufacturer’s recall instructions.

FDA recall notice

Baxter: potential fibreglass particles

Baxter recalled two lots of 0.9% Sodium Chloride Injection USP, 500 mL VIAFLEX containers: Y495523 and Y495523A. The company announcement was dated 25 August and the FDA page 26 August 2026. Potential fibreglass particulate matter could cause embolism, permanent organ damage or death. Users were instructed to stop using affected units and return them in accordance with the recall notice.

FDA recall notice

Tecfidera (dimethyl fumarate): serious gastrointestinal reactions

Health Canada’s August 2026 Health Product InfoWatch and product monograph control number 306729 describe serious gastrointestinal reactions, including gastrointestinal bleeding, obstruction, ulceration and perforation; some reported cases were fatal. Patients with new or worsening severe gastrointestinal symptoms should be evaluated promptly, and treatment should be discontinued when clinically indicated in accordance with the official product information.

Health Canada InfoWatch · Tecfidera product monograph

EMA PRAC meeting agenda

The agenda for the PRAC meeting of 31 August–3 September 2026 is an administrative pharmacovigilance update. It should not be interpreted as a new final safety recommendation or a new clinical signal by itself.

EMA PRAC meeting page

Source-based regulatory summary for pharmacovigilance professionals. This publication does not replace the official product information or instructions from regulators and manufacturers.