Delivery Method: Via Email Reference #: 320-25-102 Product: Drugs Recipient: Recipient Name Dr. K Suresh Babu Recipient Title Head – Corporate Quality and Regulatory Affairs Hikal Limited 72 - 82 / A Kiadb Industrial Area Jigani 560105 Karnataka India …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Addyi (flibanserin) Drug hypersensitivity The "Contraindications", "Warnings and Precautions", "Adverse Reactions", and "Medication Guide" sections of the labeling were updated in September 2021 to include …
Adcetris (brentuximab vedotin) Guillain-Barre syndrome FDA determined that no action is necessary at the time based on available information. Arzerra (ofatumumab) Gazyva (obinutuzumab) Riabni (rituximab-arrx) Rituxan (rituximab) Rituxan Hycela (rituximab …
Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information…
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Summary Company Announcement Date: August 27, 2025 FDA Publish Date: August 28, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety - Potential Burkholderia cepacian contamination Company Name: DermaRite …
Summary Company Announcement Date: August 27, 2025 FDA Publish Date: August 28, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Potential Contaminant – cesium-137 (Cs-137) Company Name: …
Summary Company Announcement Date: August 28, 2025 FDA Publish Date: August 28, 2025 Product Type: Food & Beverages Shellfish Contaminants Reason for Announcement: Recall Reason Description Potential Contaminant – cesium-137 (Cs-137) Company Name: …
During routine pharmacovigilance, FDA identified six fatal cases of amyloid related imaging abnormalities with edema (ARIA-E) early in treatment. These fatalities prompted an in-depth analysis of serious and fatal outcomes of ARIA-E occurring prior to the …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Summary Company Announcement Date: August 27, 2025 FDA Publish Date: August 27, 2025 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Mislabel Company Name: Unichem Pharmaceuticals Brand Name: Brand Name(s) …
Clozapine is an atypical antipsychotic medicine used to treat people who are severely ill with schizophrenia who remain symptomatic on other schizophrenia medicines. Clozapine is thought to work by balancing the brain’s levels of dopamine and serotonin, …
[8/27/2025] FDA's Center for Drug Evaluation and Research, Office of New Drugs has accepted a Letter of Intent for the qualification of Liver Stiffness Measurement by Vibration-Controlled Transient Elastography as a reasonably likely surrogate endpoint …
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Delivery Method: Via UPS and EMAIL Reference #: CBER 25-705090 Product: Biologics Recipient: Recipient Name Beeben Russell Recipient Title Chairman of the Board Platinum Biologics LLC 1510 E Colonial Drive, Suite 103 Orlando, FL 32803 United States support …
Delivery Method: VIA UPS and Electronic Mail Reference #: CBER 25-695592 Product: Biologics Recipient: Recipient Name Travis Whitney, NMD, DAASCP, MSc, MSAc Recipient Title Founder and Chief Medical Officer Innate Healthcare Institute 4835 East Cactus Road …
[8-22-2025] The Food and Drug Administration is advising consumers not to purchase or use PAIN FLEX, a product promoted and sold for joint pain on various websites, including Amazon.com and possibly in some retail stores. FDA laboratory analysis confirmed …
Delivery Method: Via Email Product: Drugs Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER July 29, 2025 RE: 711274 Dear AlzClipp: This letter is to advise you that the United States Food and Drug Administration ( …
01 days 21:56:35
