Alerts

FDA issued recall of ceftriaxone for injection by Lupin Pharmaceuticals due to particulate matter.

FDA issued recall of losartan potassium tablets, USP by Torrent Pharmaceuticals Limited due to impurity.

FDA issued recall of CAmlodipine/Valsartan Tablets USP, Valsartan/HCTZ Tablets, USP and Valsartan Tablets USP by Aurobindo due to NDEA (N-Nitrosodiethylamine) impurity.

Fluoroquinolones administered orally or intravenously may increase the risk of ruptures or tears in the main artery of the body, also known as the aorta, in certain patients.

Sandoz Inc. voluntarily recalled tablets of losartan potassium co-formulated with hydrochlorothiazide.

Symptoms of differentiation syndrome are not being recognized in patients receiving enasidenib for the treatment of acute myeloid leukemia (AML).

Alemtuzumab (Lemtrada) administered in patients with multiple sclerosis (MS) can increase the risk of hemorrhagic and ischemic stroke and tearing of the arterial vessel walls in the head and neck.

Discontinuing fingolimod (Gilenya) may worsen multiple sclerosis (MS) disease severity compared to pretreatment baseline or while on the medication.

FDA released a safety alert regarding EpiPen® auto-injectors, and their generic alternatives, sticking to their carrier tubes which could delay or prevent administration.

Sciegen Pharmaceuticals voluntarily recalled several unexpired lots of irbesartan tablets labeled for Westminster Pharmaceuticals and Golden State Medical Supply, Inc (GSMS).

Roche Diagnostics has recalled 43 lots of CoaguChek XS PT test strips to the patient level (Class I recall).

On August 29, 2018, FDA issued a warning that sodium-glucose cotransporter-2 (SGLT2) inhibitors are linked to a rare but serious infection of the genital area, known as necrotizing fasciitis of...

The FDA is notifying the public that Camber Pharmaceuticals, Inc is voluntarily recalling montelukast tablets due to mislabeling concerns.

FDA issued a warning to not prescribe the antibiotic, azithromycin, to patients for long-term prophylactic use post stem cell transplant due to a potential increased risk of cancer relapse and...

FDA is strengthening the warnings in the product labeling and Medication Guides for systemic (oral or injectable) fluoroquinolones regarding blood sugar and mental health effects.

Over-the-counter (OTC) benzocaine products can cause methemoglobinemia. Methemoglobinemia is a rare condition that reduces the amount of oxygen carried in the blood.

Synthetic cannabinoid use is linked to multiple cases of severe bleeding, including several deaths.

Dolutegravir use may carry a potential risk for neural tube birth defects in women using the drug at the time of conception or in early pregnancy.

FDA is requiring a new warning be added to the labeling of lamotrigine, which is used to treat seizures and bipolar disorders in patients 2 years of age or older.

Sagent Pharmaceuticals is voluntarily recalling 10 lots of methylprednisolone sodium succinate for injection 40 mg, 125 mg, and 1 g vials.

Apace Packaging LLC is voluntarily recalling acyclovir (Zovirax) tablets due to mislabeling concerns.

FDA has added a warning to the product labeling of clarithromycin about increased risk of delayed heart disease or death in patients with heart disease.

This includes a new black-box warning to highlight the importance of proper dosing based upon hepatic function, as well as a new Medication Guide requirement for patient education.

International Laboratories LLC is voluntarily recalling clopidogrel 75 mg tablets due to mislabeling concerns.