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FDA Roundup: March 14, 2025

FDA Roundup: March 14, 2025

May 12, 2025 0

The U.S. Food and Drug Administration is providing an at-a-glance summary of new...

FDA Roundup: March 21, 2025

FDA Roundup: March 21, 2025

May 12, 2025 0

The U.S. Food and Drug Administration is providing an at-a-glance summary of new...

HHS, FDA Announce Chemical Contaminants Transparency Tool for Foods

HHS, FDA Announce Chemical Contaminants Transparency To...

May 12, 2025 0

Under the leadership of HHS Secretary Robert F. Kennedy, Jr., the FDA unveiled a...

FDA Commissioner Makary Announces New Policy on Individuals Serving on FDA Advisory Committees

FDA Commissioner Makary Announces New Policy on Individ...

May 12, 2025 0

FDA Commissioner Martin A. Makary, M.D., M.P.H. announces a policy directive tha...

ANI Pharmaceuticals Announces FDA Approval for Expansion of Iluvien Label

ANI Pharmaceuticals Announces FDA Approval for Expansio...

May 12, 2025 0

BAUDETTE, Minn., March 14, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (N...

FDA Approves Novartis Radioligand Therapy Pluvicto for Earlier Use Before Chemotherapy in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

FDA Approves Novartis Radioligand Therapy Pluvicto for ...

May 12, 2025 0

Basel, March 28, 2025 – Novartis announced today that the US Food and Drug Admin...

Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination

Bionpharma Inc. Issues Voluntary Nationwide Recall of A...

May 12, 2025 0

Audience: Healthcare Provider, Pharmacy, Consumer September 17, 2024 – Princeton...

C&A Naturistics Issues Voluntary Nationwide Recall of AK Forte Tablets con Ortiga y Omega 3 Due to the Presence of Undeclared Drug Ingredients

C&A Naturistics Issues Voluntary Nationwide Recall of A...

May 12, 2025 0

Audience: Consumers October 16, 2024 – National City, CA, C&A Naturistics is vol...

FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy

FDA Requires Guillain-Barré Syndrome (GBS) Warning in t...

May 12, 2025 0

Audience: Patient, Health Care Professional, Pharmacy, Immunology, Pulmonology I...

Astellas Issues Recall of One Lot of Prograf 0.5 mg and One Lot of Astagraf XL 0.5 mg Because Bottles Shipped to U.S. May Contain Empty Capsules

Astellas Issues Recall of One Lot of Prograf 0.5 mg and...

May 12, 2025 0

Audience: Healthcare Provider, Pharmacy, Consumer NORTHBROOK, IL, Dec. 23, 2024 ...

Alcon Laboratories Issues Voluntary Nationwide Recall of One Lot of Systane Lubricant Eye Drops Ultra PF Due to Fungal Contamination

Alcon Laboratories Issues Voluntary Nationwide Recall o...

May 12, 2025 0

Audience: Healthcare Provider, Pharmacy, Consumer December 21, 2024 – Fort Worth...

FDA Warns Health Care Professionals Not to Use Epinephrine Nasal Solutions from BPI Labs and Endo USA

FDA Warns Health Care Professionals Not to Use Epinephr...

May 12, 2025 0

Audience: Health Care Professionals January 16, 2025 -- FDA is warning health ca...

Provepharm Inc. Issues Recall of One Lot of Phenylephrine Hydrochloride Injection, USP, 10 mg/ mL (Pharmacy Bulk Package) Due to Presence of Particulate Matter

Provepharm Inc. Issues Recall of One Lot of Phenylephri...

May 12, 2025 0

Audience: Pharmacy, Consumer January 24, 2025 – Collegeville, Pennsylvania, Prov...

Drug Safety Communication: Copaxone, Glatopa (glatiramer acetate) - FDA Adds Boxed Warning About a Rare but Serious Allergic Reaction Called Anaphylaxis

Drug Safety Communication: Copaxone, Glatopa (glatirame...

May 12, 2025 0

Audience: Patient, Caregiver, Health Care Professional, Pharmacy, Neurology ISSU...

Alvogen Issues Voluntary Nationwide Recall for One Lot of Fentanyl Transdermal System 25 mcg/h Due to a Defective Delivery System

Alvogen Issues Voluntary Nationwide Recall for One Lot ...

May 12, 2025 0

Audience: Consumer, Health Professional, Pharmacy January 31, 2025 – Morristown,...

ICU Medical Issues Nationwide Recall of Potassium Chloride Injection, 20 mEq and Potassium Chloride Injection, 10 mEq Due to Mislabeling

ICU Medical Issues Nationwide Recall of Potassium Chlor...

May 12, 2025 0

Audience: Consumer, Health Professional, Pharmacy February 13, 2025 LAKE FOREST,...

Natural Dior LLC Issues Voluntary Nationwide Recall of Vitafer-L Gold Liquid Due to Presence of Undeclared Tadalafil

Natural Dior LLC Issues Voluntary Nationwide Recall of ...

May 12, 2025 0

Audience: Consumer Natural Dior LLC (USA) – February 25, 2025 – Natural ...

CAPS Issues Recall of Phenylephrine 40 mg Added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bags Due to Visible Black Particulate Matter in a Single-Sealed Vial

CAPS Issues Recall of Phenylephrine 40 mg Added to 0.9%...

May 12, 2025 0

Audience: Pharmacy, Health Care Professional February 24, 2025 – Bethlehem, PA. ...

Limited Number of Voluntary Recalls Initiated after FDA Testing of Acne Products for Benzene

Limited Number of Voluntary Recalls Initiated after FDA...

May 12, 2025 0

Audience: Consumer, Pharmacy March 11, 2025 -- FDA is alerting the public and in...

Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) Due to Increased Reports of Allergic/Hypersensitivity Reactions

Voluntary Lot Withdrawals of Immune Globulin Intravenou...

May 12, 2025 0

Audience: Patient, Health Professional, Pharmacy, Immunology March 10, 2025 -- A...

One Source Nutrition, Inc. Issues Voluntary Nationwide Recall of Vitality Capsules Due to Presence of Undeclared Sildenafil and Tadalaﬁl

One Source Nutrition, Inc. Issues Voluntary Nationwide ...

May 12, 2025 0

Audience: Consumer Benton, Arkansas – 03/03/2025 –One Source Nutrition is volunt...

Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., Due to Mislabeling of Infusion Bag

Dr. Reddy’s Issues a Nationwide Recall of Levetiracetam...

May 12, 2025 0

Audience: Pharmacy, Health Care Professional March 13, 2025 -- Dr. Reddy’s Labor...

FDA Advises Consumers Not to Inhale Nitrous Oxide Products

FDA Advises Consumers Not to Inhale Nitrous Oxide Products

May 12, 2025 0

Audience: Consumer, Health Professional, Pulmonology March 14, 2025 -- FDA advis...

FDA Warns Consumers Not to Use Counterfeit Ozempic (semaglutide) Found in U.S. Drug Supply Chain

FDA Warns Consumers Not to Use Counterfeit Ozempic (sem...

May 12, 2025 0

Audience: Consumers April 14, 2025 -- FDA was notified by Novo Nordisk on April ...

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