Sunstar Americas Inc. (SAI) issued a voluntary recall of specific lots of chlorhexidine gluconate 0.12% oral rinse with an expiration date between 6/30/2022 – 9/30/2022 due to possible bacterial contamination with Burkholderia lata....
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Some metformin hydrochloride extended-release (ER) products, including brand-name Fortament and Glumetza, may contain low concentrations of a probable human carcinogen called N-nitrosodimethylamine (NDMA)....
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FDA issued a Drug Safety Communication recommending against non-steroidal anti-inflammatory drug (NSAID) use in pregnant women at 20 weeks or later due to serious and rare kidney complications in an unborn baby....
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FDA issued an update to the benzodiazepine drug class boxed warning to emphasize the serious risk of addiction, abuse, and withdrawal reactions....
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FDA recently issued a MedWatch alert warning consumers about serious harm with diphenhydramine when taken in amounts exceeding the recommended dose. The warning is in response to recent reports of teenagers taking high doses of diphenhydramine as part of a "Benadryl Challenge" popularized on the social media platform TikTok, which have resulted in serious harm and even death....
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Acella LLC is recalling specific lots of 15 mg and 120 mg levothyroxine (T4) and liothyronine (T3) thyroid tablets, USP (NP Thyroid) due to sub potency identified during testing....
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Certain hand sanitizers labeled with ethanol (ethyl alcohol) or isopropyl alcohol as the primary ingredient have been found to contain subpotent concentrations of these ingredients or to contain methanol or 1-propanol instead....
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Ferring Pharmaceuticals US is recalling the following desmopressin nasal spray products for possible superpotency identified during routine product testing....
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Manufacturers are being required by the FDA to add recommendations about naloxone to prescribing information for all opioids, including buprenorphine and methadone which are used to treat opioid use disorder (OUD)....
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Two lot numbers of dexmedetomidine hydrochloride (Precedex) 200 mcg/50 ml injection have been recalled by Fresenius Kabi USA due to the potential of lidocaine contamination....
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FDA released a safety alert regarding the possible reduced antiviral activity of remdesivir when administered concomitantly with hydroxychloroquine sulfate or chloroquine phosphate....
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Humans should never ingest any drug intended for use in animals, as it can cause serious harm. Drugs intended for animals cannot be substituted for those intended for humans....
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The FDA has not approved any treatments or vaccines for COVID-19 as of yet.
The only way to obtain an approved test for COVID-19 or for any type of treatment is through a health care provider....
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FDA issued a warning about the risk of transmitting multidrug resistant organisms (MRDOs) via fecal microbiota transplant (FMT). Patients considering FMT for C difficile should discuss the associated risks with their health care provider....
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FDA announced that montelukast (Singulair) would require a boxed warning and Medication Guide related to increased risk for neuropsychiatric events....
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High concentrations of biotin in the blood can interfere with some laboratory tests leading to misinterpretation of test results and incorrect patient diagnoses....
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The use of tetrahydrocannabinol (THC) vaping products, particularly those containing vitamin E acetate, may cause respiratory illnesses. FDA is now warning consumers to stop using all vaping products containing THC....
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Medications used to treat hepatitis C virus (HCV) infections containing protease inhibitors can cause further liver dysfunction in patients with liver impairment....
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Heritage Pharmaceuticals issued a voluntary recall of specific lots of amikacin sulfate and prochlorperazine edisylate injections on May 28, 2019, due to possible lack of sterility....
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Sudden discontinuation or rapid dose reduction of prescription opioids in patients who are physically dependent on these medications can cause serious harm including psychological distress, serious withdrawal symptoms, suicide, and uncontrolled pain....
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Prinston Pharmaceutical Inc. recalled tablets of irbesartan and irbesartan co-formulated with hydrochlorothiazide. The recall affects 1 lot of irbesartan and 7 lots of irbesartan-hydrochlorothiazide. One of the raw ingredients, irbesartan, USP, made by Zhejiang Huahai Pharmaceutical Co. contains the contaminant N-nitrosodiethylamine (NDEA). ...
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FDA issued a warning that tofacitinib (Xeljanz, Xeljanz XR) may increase the risk of pulmonary embolism in patients with rheumatoid arthritis....
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FDA is strengthening warnings in the febuxostat (Uloric) product labeling and has added a Medication Guide requirement because of an increased risk of cardiovascular death and all-cause mortality....
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The FDA is notifying the public that Dr. Reddy’s Laboratories Ltd. is voluntarily recalling levetiracetam injection bags due to mislabeling....
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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....
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Symptoms of differentiation syndrome are not being recognized in patients receiving enasidenib for the treatment of acute myeloid leukemia (AML)....
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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....
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Discontinuing fingolimod (Gilenya) may worsen multiple sclerosis (MS) disease severity compared to pretreatment baseline or while on the medication....
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FDA released a safety alert regarding EpiPen® auto-injectors, and their generic alternatives, sticking to their carrier tubes which could delay or prevent administration....
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Sciegen Pharmaceuticals voluntarily recalled several unexpired lots of irbesartan tablets labeled for Westminster Pharmaceuticals and Golden State Medical Supply, Inc (GSMS)....
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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 perineum....
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The FDA is notifying the public that Camber Pharmaceuticals, Inc is voluntarily recalling montelukast tablets due to mislabeling concerns....
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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 death....
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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....
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Over-the-counter (OTC) benzocaine products can cause methemoglobinemia. Methemoglobinemia is a rare condition that reduces the amount of oxygen carried in the blood....
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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....
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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....
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Sagent Pharmaceuticals is voluntarily recalling 10 lots of methylprednisolone sodium succinate for injection 40 mg, 125 mg, and 1 g vials....
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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....
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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....
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The FDA is now requiring new information in the labeling of these products describing the risks of use in children or breastfeeding women....
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The manufacturer, Tesaro, recommends that healthcare providers watch for hypersensitivity or anaphylaxis during and following rolapitant administration....
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The FDA issued a communication detailing an approach to possibly continue benzodiazepines or CNS depressants with opioid addiction medications, buprenorphine or methadone....
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The FDA published an alert describing hemorrhagic occlusive retinal vasculitis (HORV) associated with compounded triamcinolone, moxifloxacin, and vancomycin (TMV) intraocular injection from Imprimis Pharmaceuticals, Inc....
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Sodium polystyrene sulfonate, known by the brand name Kayexalate, binds to commonly used oral medications, decreasing their absorption and potentially their effectiveness....
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Pembrolizumab (Keytruda) in combination with dexamethasone and either lenalidomide or pomalidomide increased the risk of death in patients with multiple myeloma based on interim analyses from 2 phase 3 clinical trials....
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The PharmaTech recall of oral liquid docusate products has been expanded. FDA now recommends not using any liquid products manufactured by PharmaTech. ...
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Amneal is voluntarily recalling certain lots of lorazepam 2 mg/mL oral concentrate (NDC 65162-0687-84), which contain misprinted dosing droppers....
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Apace Packaging LLC is voluntarily recalling one lot each of cyclobenzaprine and amantadine 50-count unit dose boxes due to mislabeling concerns....
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AstraZeneca is voluntarily recalling ticagrelor (Brilinta) 90 mg physician sample bottles because they may also contain lesinurad (Zurampic) 200 mg tablets, another AstraZeneca product....
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Lupin Pharmaceuticals Inc. recalled lot L600518, expiry 05/18 of Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol 1 mg/0.02 mg and ferrous fumarate 75 mg) chewable tablets....
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Genetic Edge Compounds is voluntarily recalling GEC Laxoplex due to FDA concerns regarding the presence of anabolic steroids and other steroid-like substances....
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Hospira Inc., is voluntarily recalling one lot (NDC 0408-1775-10, Lot # 58382EV) of 25% Dextrose Injection, USP (Infant) prefilled syringes....
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FDA is warning consumers and health care professionals that several companies have sold products illegally claiming to prevent, diagnose, treat, or cure cancer....
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FDA issued a warning about the risk of adverse effects from all homeopathic teething tablets and gels. The company has agreed to conduct a recall of their belladonna homeopathic teething products as of April 2017....
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Kingsway Trading Inc. is recalling its dietary supplement Well Balance Xanthium & Siler Combo (Bi Yan Pian) due to the presence of ephedra herba (ma huang) in the product....
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FDA is informing patients and health care professionals that magnetic resonance (MR) environments can cause implantable infusion pump errors resulting in patient harm and death....
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FDA received a cluster of bleeding event reports in 2016 associated with the Vascu-Guard Peripheral Vascular Patch from Baxter International. ...
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FDA is adding a new boxed warning to all opioid medications and benzodiazepines about the risk of serious adverse effects with concomitant use. FDA reviewed 6 studies regarding opioid use with benzodiazepines....
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