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FDA Drug Alerts
FDA DRUG ALERTS
OCT
24
Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions
By:
on
OCT
24
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...
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OCT
21
FDA Provides Update to Health Care Professionals About Risk of Inadvertent Intrathecal (Spinal) Administration of Tranexamic Acid Injection
By:
on
OCT
21
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...
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OCT
10
FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-Associated Enterocolitis Following Treatment with Carvykti (ciltacabtagene autoleucel)
By:
on
OCT
10
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...
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OCT
10
FDA’s Actions to Protect Children from Contaminated Cough Medicine
By:
on
OCT
10
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...
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SEP
25
FDA Removes Risk Evaluation and Mitigation Strategies (REMS) for Caprelsa (vandetanib)
By:
on
SEP
25
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...
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AUG
27
FDA Removes Risk Evaluation and Mitigation Strategy (REMS) Program for the Antipsychotic Drug Clozapine
By:
on
AUG
27
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...
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AUG
27
Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling
By:
on
AUG
27
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...
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AUG
22
FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live)
By:
on
AUG
22
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...
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AUG
19
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
By:
on
AUG
19
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...
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AUG
08
DermaRite Industries Issues Recall of DermaKleen, Dermasarra, Kleenfoam, and Perigiene Products Due to Burkholderia cepacia Contamination
By:
on
AUG
08
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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