Ostrzeżenia FDA dotyczące leków

OSTRZEŻENIA FDA DOTYCZĄCE LEKÓW

FDA Investigating Deaths Due to Acute Liver Failure Following Treatment with Sarepta’s AAVrh74 Gene Therapies

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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FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine

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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Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging

Audience: Consumer, Health Professional, Pharmacy UPDATE July 14, 2025 – Sandoz, Inc. (“Sandoz”) is initiating a voluntary nationwide recall expansion of one additional lot of Cefazolin for Injection, USP, 1 gram per vial. The lot...

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Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry

Audience: Consumer, Pharmacy, Health Care Professional NEW YORK, DC, UNITED STATES, July 11, 2025 -- Nostrum Laboratories, Inc. (“Nostrum Labs”) filed Chapter 11 bankruptcy on September 30, 2024. In connection with that filing, the...

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FDA Requires Expanded Labeling About Weight Loss Risk in Patients Younger Than 6 Years Taking Extended-Release Stimulants for ADHD

Audience: Consumer, Pharmacy, Health Care Professional FDA Drug Safety Communication - June 30, 2025 What safety concern is FDA announcing?The U.S. Food and Drug Administration (FDA) is revising the labeling of all extended-release stimulants...

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FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination

Audience: Consumer, Patient, Health Care Professional, Pharmacy FDA Safety Communication June 25, 2025 Purpose: To inform the public and healthcare providers that FDA has required and approved updates to the Prescribing Information for Comirnaty...

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Drug Safety Communication: FDA Investigating Deaths Due to Acute Liver Failure in Non-Ambulatory Duchenne Muscular Dystrophy Patients Following Elevidys

Audience: Health Care Professional FDA Safety Communication – June 24, 2025 -- Since approval, the Food and Drug Administration (FDA) has received two reports of fatal acute liver failure following treatment of non-ambulatory pediatric male...

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FDA Adds Warning About Serious Risk of Heat-Related Complications With Antinausea Patch Transderm Scōp (scopolamine transdermal system)

Audience: Consumer, Health Care Professional June 18, 2025 FDA Drug Safety Communication What safety concern is FDA announcing? The U.S. Food and Drug Administration (FDA) is warning that the antinausea patch Transderm Scōp (scopolamine...

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Medtech Products Inc. Issues Nationwide Recall of Little Remedies Honey Cough Syrup Due to Microbial Contamination

Audience: Consumer, Pharmacy TARRYTOWN, N.Y.--(GLOBE NEWSWIRE)—June 17, 2025—Medtech Products Inc., a Prestige Consumer Healthcare Inc. company (“Medtech” or “Company”), is voluntarily recalling five lots of...

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Church & Dwight Issues Voluntary Nationwide Recall of Zicam Cold Remedy Nasal Swabs, Zicam Nasal AllClear Swabs, and Orajel Baby Teething Swabs Due to Microbial Contamination

Audience: Consumer June 06, 2025 -- Church & Dwight Co., Inc. is voluntarily recalling all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs to the consumer level...

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