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FDA Drug Alerts
FDA DRUG ALERTS
JUL
18
FDA Investigating Deaths Due to Acute Liver Failure Following Treatment with Sarepta’s AAVrh74 Gene Therapies
By:
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
By:
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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JUL
14
Sandoz Inc. Issues Voluntary Nationwide Recall of One Lot of Cefazolin for Injection Due to Product Mispackaging
By:
on
JUL
14
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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JUL
11
Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Sucralfate Tablets USP 1 Gram Within Expiry
By:
on
JUL
11
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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JUN
30
FDA Requires Expanded Labeling About Weight Loss Risk in Patients Younger Than 6 Years Taking Extended-Release Stimulants for ADHD
By:
on
JUN
30
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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JUN
25
FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination
By:
on
JUN
25
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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JUN
24
Drug Safety Communication: FDA Investigating Deaths Due to Acute Liver Failure in Non-Ambulatory Duchenne Muscular Dystrophy Patients Following Elevidys
By:
on
JUN
24
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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JUN
18
FDA Adds Warning About Serious Risk of Heat-Related Complications With Antinausea Patch Transderm Scōp (scopolamine transdermal system)
By:
on
JUN
18
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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JUN
17
Medtech Products Inc. Issues Nationwide Recall of Little Remedies Honey Cough Syrup Due to Microbial Contamination
By:
on
JUN
17
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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JUN
06
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
By:
on
JUN
06
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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