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AUG
27
FDA Removes Risk Evaluation and Mitigation Strategy (REMS) Program for the Antipsychotic Drug Clozapine
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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
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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)
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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
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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
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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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AUG
07
FDA Approves Required Labeling Changes for Increased Risk of Hematologic Malignancy Following Treatment with Skysona (elivaldogene autotemcel)
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on
AUG
07
Audience: Health Professional August 7, 2025 -- In November 2024, FDA issued a safety communication, “FDA Investigating Serious Risk of Hematologic Malignancy Following Skysona (elivaldogene autotemcel),” to provide information on...
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JUL
31
FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks
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on
JUL
31
Audience: Consumer, Pharmacy, Health Care Professional July 31, 2025 -- The U.S. Food and Drug Administration is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associated with their...
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JUL
29
FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers
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on
JUL
29
Audience: Consumer July 29, 2025 -- The U.S. Food and Drug Administration today is taking a bold step to protect Americans from dangerous, illegal opioids by recommending a scheduling action to control certain 7-hydroxymitragynine (also known as...
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JUL
18
FDA Investigating Deaths Due to Acute Liver Failure Following Treatment with Sarepta’s AAVrh74 Gene Therapies
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on
JUL
18
Audience: Health Care Professional As of July 18, 2025, the Food and Drug Administration (FDA) has received three reports of fatal acute liver failure following treatment of patients with Sarepta AAVrh74 gene therapies that appear to have been...
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JUL
15
FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine
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on
JUL
15
Audience: Industry July 15, 2025 -- The U.S. Food and Drug Administration today announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH.1 This action reflects the...
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