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.... Read More
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).... Read More
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.... Read More
FDA issued an update to the benzodiazepine drug class boxed warning to emphasize the serious risk of addiction, abuse, and withdrawal reactions.... Read More
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.... Read More
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.... Read More
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.... Read More
New clinical trial data compelled FDA to remove the boxed warning on canagliflozin products regarding the risk of amputation.... Read More
Ferring Pharmaceuticals US is recalling the following desmopressin nasal spray products for possible superpotency identified during routine product testing.... Read More
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).... Read More
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.... Read More
FDA released a safety alert regarding the possible reduced antiviral activity of remdesivir when administered concomitantly with hydroxychloroquine sulfate or chloroquine phosphate.... Read More
The FDA cautions against use of hydroxychlorquine and chloroquine outside of a hospital setting or clinical trial.... Read More
International Laboratories, LLC is voluntarily recalling lot # 117099A of clopidogrel 75 mg tablets in 30-count bottles.... Read More
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.... Read More
Updated findings suggest that COVID-19 may be transmitted through FMT.... Read More
FDA requested all manufacturers of ranitidine products to immediately withdraw their products from the US market.... Read More
Animal drugs are not interchangeable with human drugs.... Read More
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.... Read More
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.... Read More
FDA announced that montelukast (Singulair) would require a boxed warning and Medication Guide related to increased risk for neuropsychiatric events.... Read More
Health care providers should stop prescribing and dispensing lorcaserin immediately.... Read More
FDA Updates Warnings for Bowel Problems Associated with Clozapine... Read More
Increased risk of respiratory depression when using gabapentin or pregabalin.... Read More
High concentrations of biotin in the blood can interfere with some laboratory tests leading to misinterpretation of test results and incorrect patient diagnoses.... Read More
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.... Read More
Voluntarily recalled tablets of losartan potassium co-formulated with hydrochlorothiazide.... Read More
Cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors can cause lung inflammation when used to treat advanced breast cancers.... Read More
Medications used to treat hepatitis C virus (HCV) infections containing protease inhibitors can cause further liver dysfunction in patients with liver impairment.... Read More
New warning draws attention to the increased risk of blood clots and death associated with higher doses of tofacitinib.... Read More
Altaire issued the retail level recall over quality concerns at their manufacturing facility.... Read More
FDA issued a warning about the risk of transmitting multidrug resistant organisms (MRDOs) via fecal microbiota transplant (FMT).... Read More
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.... Read More
Use of certain insomnia medications has caused complex sleep behaviors resulting in serious harm or death.... Read More
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.... Read More
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). ... Read More
More manufacturers have recently recalled their valsartan products.... Read More
FDA issued a warning that tofacitinib (Xeljanz, Xeljanz XR) may increase the risk of pulmonary embolism in patients with rheumatoid arthritis.... Read More
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.... Read More
Apotex Corp. voluntarily recalled drospirenone and ethinyl estradiol tablets.... Read More
The FDA is notifying the public that Dr. Reddy’s Laboratories Ltd. is voluntarily recalling levetiracetam injection bags due to mislabeling.... Read More
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.... Read More
Sandoz Inc. voluntarily recalled tablets of losartan potassium co-formulated with hydrochlorothiazide.... Read More
Symptoms of differentiation syndrome are not being recognized in patients receiving enasidenib for the treatment of acute myeloid leukemia (AML).... Read More
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.... Read More
Discontinuing fingolimod (Gilenya) may worsen multiple sclerosis (MS) disease severity compared to pretreatment baseline or while on the medication.... Read More
FDA released a safety alert regarding EpiPen® auto-injectors, and their generic alternatives, sticking to their carrier tubes which could delay or prevent administration.... Read More
Sciegen Pharmaceuticals voluntarily recalled several unexpired lots of irbesartan tablets labeled for Westminster Pharmaceuticals and Golden State Medical Supply, Inc (GSMS).... Read More
Roche Diagnostics has recalled 43 lots of CoaguChek XS PT test strips to the patient level (Class I recall).... Read More
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.... Read More
The FDA is notifying the public that Camber Pharmaceuticals, Inc is voluntarily recalling montelukast tablets due to mislabeling concerns.... Read More
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.... Read More
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.... Read More
Over-the-counter (OTC) benzocaine products can cause methemoglobinemia. Methemoglobinemia is a rare condition that reduces the amount of oxygen carried in the blood.... Read More
Synthetic cannabinoid use is linked to multiple cases of severe bleeding, including several deaths.... Read More
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.... Read More
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.... Read More
Sagent Pharmaceuticals is voluntarily recalling 10 lots of methylprednisolone sodium succinate for injection 40 mg, 125 mg, and 1 g vials.... Read More
Apace Packaging LLC is voluntarily recalling acyclovir (Zovirax) tablets due to mislabeling concerns.... Read More
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.... Read More
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.... Read More
International Laboratories LLC is voluntarily recalling clopidogrel 75 mg tablets due to mislabeling concerns.... Read More
Magno-Humphries Laboratories Inc is voluntarily recalling Basic Drugs Brand Senna Laxative tablets due to mislabeling concerns.... Read More
The FDA is now requiring new information in the labeling of these products describing the risks of use in children or breastfeeding women.... Read More
The manufacturer, Tesaro, recommends that healthcare providers watch for hypersensitivity or anaphylaxis during and following rolapitant administration.... Read More
Gadolinium-based contrast agents (GBCAs) can remain in patients’ bodies for months to years after administration.... Read More
FDA issued a MedWatch alert concerning the use of Limbrel and risk of drug-induced liver injury and hypersensitivity pneumonitis.... Read More
Fresenius Kabi USA is recalling midazolam injection 2 mg/2 mL prefilled syringes due to mislabeling concerns.... Read More
The FDA issued a communication detailing an approach to possibly continue benzodiazepines or CNS depressants with opioid addiction medications, buprenorphine or methadone.... Read More
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.... Read More
Sodium polystyrene sulfonate, known by the brand name Kayexalate, binds to commonly used oral medications, decreasing their absorption and potentially their effectiveness.... Read More
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.... Read More
The PharmaTech recall of oral liquid docusate products has been expanded. FDA now recommends not using any liquid products manufactured by PharmaTech. ... Read More
The FDA is warning of high levels of lead in the supplement, Balguti Kesaria Ayurvedic.... Read More
Amneal is voluntarily recalling certain lots of lorazepam 2 mg/mL oral concentrate (NDC 65162-0687-84), which contain misprinted dosing droppers.... Read More
International Laboratories, LLC is voluntarily recalling pravastatin 40 mg tablets due to mislabeling concerns.... Read More
Apace Packaging LLC is voluntarily recalling one lot each of cyclobenzaprine and amantadine 50-count unit dose boxes due to mislabeling concerns.... Read More
The device cartridge may break or crack if exposed to chemicals or cleaning agents.... Read More
AstraZeneca is voluntarily recalling ticagrelor (Brilinta) 90 mg physician sample bottles because they may also contain lesinurad (Zurampic) 200 mg tablets, another AstraZeneca product.... Read More
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.... Read More
Genetic Edge Compounds is voluntarily recalling GEC Laxoplex due to FDA concerns regarding the presence of anabolic steroids and other steroid-like substances.... Read More
Hospira Inc., is voluntarily recalling one lot (NDC 0408-1775-10, Lot # 58382EV) of 25% Dextrose Injection, USP (Infant) prefilled syringes.... Read More
FDA approved a new warning in the product labeling reflecting this risk.... Read More
FDA is warning consumers and health care professionals that several companies have sold products illegally claiming to prevent, diagnose, treat, or cure cancer.... Read More
The FDA has discontinued the Risk Evaluation Mitigation Strategy (REMS) program for the erythropoiesis-stimulating agents (ESAs).... Read More
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.... Read More
Eluxadoline (Viberzi®) may cause serious, life-threatening pancreatitis in patients without a gallbladder.... Read More
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.... Read More
Due to increases in reports of anaphylaxis, a warning is now being added to the OTC Drug Facts labels.... Read More
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.... Read More
FDA received a cluster of bleeding event reports in 2016 associated with the Vascu-Guard Peripheral Vascular Patch from Baxter International. ... Read More
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.... Read More