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#安全信号

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Oct 15Thu
  1. fda.gov46

    Par Health Issues Voluntary Nationwide Recall of Argatroban Injection Due to the Presence of Particulate Matter

    Par Health USA is voluntarily recalling 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) to the hospital/user level after particulate matter identified as cellulose, polystyrene, polyethylene terephthalate, stopper material and possibly stainless steel was detected. The affected lots, distributed nationwide to wholesalers and hospitals between December 30, 2024 and May 5, 2026, carry a risk of pulmonary emboli, blood vessel occlusion and vein wall inflammation. No adverse events have been reported; distributors and hospital pharmacies should stop use and return inventory through Inmar, Inc.

Oct 9Fri
  1. fda.gov41

    Par Health Issues Voluntary Nationwide Recall of Two Lots of Brevital® Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) Due to the Presence of Particulate Matter

    Par Health is voluntarily recalling two lots of Brevital Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP), distributed by Par Pharmaceutical, to the hospital level because of particulate matter identified as cellulose. Lots 86930 (exp. 02/2028) and 88623 (exp. 04/2028), item code 42023-105-01, were distributed nationwide to wholesalers between July 8, 2025 and May 11, 2026. No adverse events have been reported; wholesale distributors and hospital pharmacies should stop use and distribution, with returns handled through Inmar, Inc.

Sep 10Thu
  1. fiercebiotech.com58

    Biohaven epilepsy drug suffers FDA hold days after attracting $350M deal

    The FDA has placed a hold on enrollment in trials of Biohaven's epilepsy drug candidate BHV-7000 after findings from rodent tests. The candidate is covered by a pending $350 million deal announced days before the hold. Biohaven has not disclosed how it will respond to the FDA.

    Why it matters: FDA halts enrollment in trials of a drug candidate tied to a pending $350 million deal.

Sep 4Fri
  1. ema.europa.eu45

    Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2026

    EMA's Pharmacovigilance Risk Assessment Committee has begun a review of all injectable iron-containing medicines over risks of hypophosphataemia and related bone problems such as osteomalacia. The review was triggered by reports questioning the effectiveness of current risk-minimisation measures for ferric carboxymaltose products, including serious cases after only one or two doses in people without recognised risk factors. PRAC will assess the benefit-risk balance and decide whether changes to marketing authorisations are needed.

    Why it matters: A EU-wide safety review of all injectable iron medicines could change prescribing and product information for iron deficiency anaemia.

Aug 20Thu
  1. fiercepharma.com41

    B. Braun recalls IV solution from US, Canada hospitals on particle contamination concerns

    B. Braun Medical is recalling one lot of Excel lactated ringers injection distributed to hospitals in the U.S. and Canada from late August through September 2024, after identifying potential particulate contamination from cellulose cotton fiber, cellulose wood fiber and polystyrene. As of Aug. 19, no adverse events had been reported, and the recall echoes a sodium chloride recall the company issued in 2024.

CBACBA Frontier Insights (CFI)Chinese Biopharmaceutical Association (CBA)www.cba-usa.org