Alertas de medicamentos de la FDA

ALERTAS DE MEDICAMENTOS DE LA FDA

Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions

Audience: Health Care Professionals October 24, 2025 -- The FDA Adverse Event Reporting System (FAERS) has received increased reporting of allergic/hypersensitivity type reactions following infusion of specific lots of Immune Globulin Intravenous...

FDA Provides Update to Health Care Professionals About Risk of Inadvertent Intrathecal (Spinal) Administration of Tranexamic Acid Injection

Audience: Health Care Professionals October 21, 2025 -- FDA is requiring labeling changes to strengthen the warnings that tranexamic acid injection should be administered only intravenously (into the vein). Tranexamic acid injection products are not...

FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-Associated Enterocolitis Following Treatment with Carvykti (ciltacabtagene autoleucel)

Audience: Patient, Health Care Professional, Pharmacy, Gastroenterology October 10, 2025 -- The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with Carvykti. Reports were...

FDA’s Actions to Protect Children from Contaminated Cough Medicine

Audience: Consumer October 10, 2025 -- FDA is aware of news reports of devastating, ongoing diethylene glycol (DEG) and ethylene glycol (EG) contamination in children’s cough and cold medicine in India. The agency has confirmed these products...

FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)

Audience: Patient, Pharmacy, Health Care Professional September 25, 2025 -- The U.S. Food and Drug Administration today removed the Risk Evaluation and Mitigation Strategies (REMS) program for Caprelsa (vandetanib), a thyroid cancer medication...

FDA Removes Risk Evaluation and Mitigation Strategy (REMS) Program for the Antipsychotic Drug Clozapine

Audience: Patient, Pharmacy, Health Care Professional August 27, 2025 -- FDA Removes Risk Evaluation and Mitigation Strategies (REMS) Program for the Antipsychotic Drug Clozapine - Neutropenia Risk Remains, but REMS No Longer Necessary and REMS May...

Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling

Audience: Consumer, Pharmacy, Health Care Professional August 27, 2025– East Brunswick, NJ, Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The...

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live)

Audience: Patient, Health Care Professional, Pharmacy, Cardiology, Neurology, Internal Medicine, Family Practice, Travel Clinics August 22, 2025 -- Today the US FDA’s Center for Biologics Evaluation and Research has suspended the biologics...

B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate Matter

Audience: Pharmacy, Health Care Professional BETHLEHEM, PA – August 19, 2025 – B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL, and 0.9% Sodium Chloride Injection USP 1000 mL...

DermaRite Industries Issues Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia Contamination

Audience: Consumer August 8, 2025 -- DermaRite Industries, LLC is voluntarily recalling individual lots of products in the table below due to microbial contamination identified as Burkholderia cepecia. Risk Statement: Burkholderia Cepacia Complex...

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