Made In India Drugs Recalled: Three Made In India Drugs Recalled In Us: Fda, Health News, Et Healthworld
New Delhi: Three different drugs made in India, including by Cadila Pharma and Alkem Laboratories , are being recalled in the US for not meeting the manufacturing norms. According to the latest Enforcement Report of the USFDA , Cadila Pharmaceuticals Ltd is recalling 6 kg of Ondansetron HCI API manufactured by the company on account of microbial contamination of non-sterile product. The voluntary ongoing recall is a class II recall, it added. "According to the firm, the API was distributed to two consignees in the US," the United States Food and Drug Administration (USFDA) said. In another case, Par Pharmaceutical Inc is recalling a total of 242,304 bottles of Travoprost ophthalmic solution USP in the strength of 0.004 per cent in 2.5 mL and 5 mL bottles, that were made in India. The reason for the recall is "lack of assurance of sterility; damage to the internal portion of the dropper tip portion of the container," the USFDA said, adding the nationwide voluntary recall was a class II recall, as per the Enforcement Report. Likewise, 1,739 bottles of Metformin Hydrochloride Tablets, USP 500 mg, manufactured by Mumbai based Alkem Laboratories are being recalled by distributing firm Ascend Laboratories LLC. "Reason for recall is presence of foreign tablets/ capsules; report of Amlodipine tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP," the Enforcement Report said. This is also a class II recall, USFDA said. As per the USFDA, a class II recall is initiated in a "situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote". Continue reading >>
Three Made In India Drugs Recalled In Us For Not Meet Manufacturing Norms: Fda
Three Made in India drugs recalled in US for not meet manufacturing norms: FDA By PTI| Published: 07th December 2016 08:47 PM| Last Updated: 07th December 2016 08:47 PM| A+AA- | NEW DELHI: Three different drugs made in India, including by Cadila Pharma and Alkem Laboratories, are being recalled in the US for not meeting the manufacturing norms. According to the latest Enforcement Report of the USFDA, Cadila Pharmaceuticals Ltd is recalling 6 kg of Ondansetron HCI API manufactured by the company on account of microbial contamination of non-sterile product. The voluntary ongoing recall is a class II recall, it added. "According to the firm, the API was distributed to two consignees in the US," the United States Food and Drug Administration (USFDA) said. In another case, Par Pharmaceutical Inc is recalling a total of 242,304 bottles of Travoprost ophthalmic solution USP in the strength of 0.004 per cent in 2.5 mL and 5 mL bottles, that were made in India. The reason for the recall is "lack of assurance of sterility; damage to the internal portion of the dropper tip portion of the container," the USFDA said, adding the nationwide voluntary recall was a class II recall, as per the Enforcement Report. Likewise, 1,739 bottles of Metformin Hydrochloride Tablets, USP 500 mg, manufactured by Mumbai based Alkem Laboratories are being recalled by distributing firm Ascend Laboratories LLC. "Reason for recall is presence of foreign tablets/ capsules; report of Amlodipine tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP," the Enforcement Report said. This is also a class II recall, USFDA said. As per the USFDA, a class II recall is initiated in a "situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse Continue reading >>
Differing Brands Of Generic Metformin Behave Differently
Dr. Bernstein has been preaching about this on his web telecasts for years, but it bears repeating: If you are having problems with generic metformin or not seeing it make much impact on your blood sugar, change brands before you assume it isn't working or that you can't tolerate it. I just had this message brought home to me when my pharmacy (Walgreens) filled my prescription for metformin ER with tablets from SunPharma instead of the ones from Teva they'd given me for years. The pills were about half the size of the ones I'd been getting, which suggested they contained less of a matrix substance to slow the release of the metformin. And sure enough, when I took the same dose I had been taking with no problems with the Teva brand metformin, I felt exhausted and semi-poisoned. It felt just like when I had taken an overdose of metformin some years ago, when my family doctor prescribed an overdose after confusing the dosage instructions for regular metformin--which can be taken in larger doses--with those of metformin ER. Not only that, but my fasting blood sugars went up. Clearly the SunPharma metformin ER was not behaving like a true extended release should and releasing slowly through a 24 hour period but was hitting my blood stream all at once and then was done. A quick visit to Google revealed that Sun Pharmaceuticals is an Indian company and that in the past the FDA has forced them to recall batches for quality issues. When it was time to refill my prescription, I called my pharmacy and spoke with the pharmacist who shrugged off my concerns and told me I'd have to speak to the pharmacy manager (not available that day.) So I got on the phone and called other local pharmacies and asked them what brand they were dispensing. Two of them still carry the Teva brand, so I Continue reading >>
Ascend Labs Metformin
Ascend Laboratories Home Page provides high-quality and cost effective generic drugs and medicines that treat a number of health issues in many therapeutic areas. It is dedicated to improving patient outcomes and reducing the cost of healthcare since launching on 3/1/2008. Ascend Laboratories Products - Ascend Laboratories LLC HYDROCHLORIDE - DailyMed - NIH , LLC. Category: Metformin hydrochloride tablets USP are oral antihyperglycemic drug used in the management of type 2 diabetes. Mechanism of Action - Metformin is an antihyperglycemic agent which viagra 50mg price improves glucose tolerance in patients with type 2 diabetes, lowering both basal and nbsp; METFORMIN HYDROCHLORIDE - DailyMed - NIH -associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and nbsp; Full List of Metformin Recalls, FDA 2012-2017 - MedPro Disposal Metformin Recalls. There have been 15 total recalls of Metformin from 2012 through 2017. The Metformin recalls involved a grand total of over 150, 000 bottles of the popular diabetes medication. The most recent was a Class II event in late 2016 from Ascend Laboratories. Several other companies have nbsp; cialis online prescription Ascend Laboratories LLC Company Information LLC manufactures, markets and/or distributes more than 33 drugs in the U.S.. 227 Pill Images (White / Round) - hydrochloride 500 mg. It is supplied by Ascend Laboratories, LLC. Diabetes Update: Differing Brands of Generic Metformin Behave The pills were about half the size of the ones I 39;d been getting, which suggested they contained less of a matrix substanc Continue reading >>
Ascend Metformin - Topics - Medschat
I have some white oblong white tablets scored on one side and printed M525 on the other. I believe these are Ascend Labs Metformin HCL ER 500 mg tablets from a couple of months ago that I didnt finish up when I got my refill prescription. They also could be a different brand that the pharmacy used to fill my prescription. ## These tablets are manufactured by Mylan Pharmaceuticals and they list them as containing 120mgs of Diltiazem. The FDA classifies this medication as a calcium channel blocker that's most commonly used to treat high blood pressure and certain cardiac conditions. Its typical side effects may possibly include nausea, dizziness, headache, stomach pain, increased urination and hypotension. Is there anything else I can help with? ... Can you tell me of a pill numbered 227 or 105 connected to metformin? ## Hello, Babs! How are you? There is a round, white tablet with 227 on it that is manufactured by Ascend Laboratories, which they list as containing 500mgs of Metformin. There is also a round, white tablet with SG on one side and 105 on the other that is manufactured by ScieGen Pharmaceuticals, which they list as containing 500mgs of Metformin. The FDA classifies this medication as an oral antidiabetic drug. Its typical side effects may possibly include nausea, dizziness, headache, flatulence, stomach pain and hypoglycemia. Is there anything else I can help with? ... Heritage Pharmaceuticals and 500 mg. Metformin Heritage brand Metformin did not work for me, but I took it for months and developed blisters around the outside of my mouth which is not herpes. Now back on Ascend Metformin and it is working for me. The blisters and inflammation are lessening but not completely gone. Has anyone had this problem and know what it is and how to treat it? ## My bloo Continue reading >>
Ascend Laboratories Llc
Triamcinolone Acetonide Cream 0.1% Tube 80gm/Tb 1240843 | Ascend Laboratories LLC 67877025180 This product is a prescription drug. If your State License number is on file we can ship this item to you. Otherwise, please include your State License number in the comments section of the order. 1247117 | Ascend Laboratories LLC 4870820 This product is a non stock item that must be ordered from the manufacturer, and as such, will appear on a separate order , follow at a later date and incur a $6.75 special order charge. This product is a prescription drug. If your State License number is on file we can ship this item to you. Otherwise, please include your State License number in the comments section of the order. This product is a non stock item that must be ordered from the manufacturer, and as such, will appear on a separate order , follow at a later date and incur a $6.75 special order charge. This product is a prescription drug. If your State License number is on file we can ship this item to you. Otherwise, please include your State License number in the comments section of the order. Silver Sulfadiazine Cream 1% Tube 50gm/Tb 1244342 | Ascend Laboratories LLC 67877012405 This product is a prescription drug. If your State License number is on file we can ship this item to you. Otherwise, please include your State License number in the comments section of the order. 1166466 | Ascend Laboratories LLC 67877021620 This product is a prescription drug. If your State License number is on file we can ship this item to you. Otherwise, please include your State License number in the comments section of the order. 1314708 | Ascend Laboratories LLC 67877032005 This new item has recently been ordered from the manufacturer and will be shipped to you upon arrival at our warehouses. Thi Continue reading >>
Full List Of Metformin Recalls, Fda 2012-2017
Metformin is a popular generic, widely used and generally well tolerated for the treatment of type 2 diabetes. If you use sharps check out this helpful article on Sharps Container Disposal. Despite being made by dozens of manufacturers around the world, to date there have been only 15 recalls of the popular drug, with most being minor. The exceptions are a 27,000 kilo recall from Smruthi Organics in early 2014, and a recall of 117,049 sample cartons from Bristol-Myers Squibb in 2012. The next biggest Metformin recall after that came from Actavis Laboratories and affected 13,284 bottles in 2015. Metformin Recalls There have been 15 total recalls of Metformin from 2012 through 2017. The Metformin recalls involved a grand total of over 150,000 bottles of the popular diabetes medication. The most recent was a Class II event in late 2016 from Ascend Laboratories. Several other companies have been the focus of Metformin recalls. Most of the incidents were relatively small, in the sub-7,000 bottles range. The biggest by pill count was a 2012 recall from Bristol-Myers Squibb that affected over 117,000 sample packs. Metformin Facts Metformin is a diabetes medication in oral form that helps manage blood sugar levels. It’s used in cases of type 2 diabetes. It’s sometimes given along with insulin and other medications. It’s not meant for type 1 diabetes. Serious side effects can include allergic reaction with difficulty breathing or facial swelling, and dangerous or even fatal lactic acidosis marked by numbness, fatigue, slow heart rate, and vomiting. More common side effects are nausea, upset stomach, vomiting, and diarrhea. Major Metformin Recalls There have been three major Metformin recalls and several minor ones. The biggest in terms of bottles/cartons was a 2012 recall Continue reading >>
Ascend Laboratories - Complete Overview Of Drugs And Treatments By Treato
We analyzed what people said about Ascend Laboratories These are marked ASC 116 on one side and scored on the other side. Are they stronger than the others that are 10 MG? FDA doesn't care we are getting inferior products, which cause problems Ascend Laboratories Metformin 500 mg tablets is the only one that works for me. I had Amneal and Heritage for two years and finally got back to Ascend and my levels are going back down. I had developed blisters around the outside of my mouth on the Heritage brand and facial inflammation. It has been 7 weeks on Ascend brand and the blisters and inflammation is finally going away. Now CVS has bought out Target pharmacies and I can't get the Ascend brand. The FDA doesn't give a damn and the pharmacies only care about their bottom line! When I first began on tammies, Rite Aid got me the ones ... Damn Mylan to hell! Same situation here, doublecheck. When I first began on tammies, Rite Aid got me the ones from Ascend Laboratories. They were 15mg, bright orange capsules, and I guess that's what I kept getting for some time to come, even from Walgreen's and drugstore dot com. They worked fine. Then one day, at Walgreen's they gave me the green and white Sandoz capsules, and those kicked ass! After all that time of taking tams, I could feel more strength in those. Then, as all read more... good things come to an end, all the chain pharms only supplies the Mylan shit. They were the same bright orange appearance as my first several refills from Ascend Labs, so I didn't think too much of it, and also realized that after those Sandoz goodies, to expect some letdown. But damn, even when I first got the Valiums scripted to me after burning out on the tams, they were fuckin Mylan too! I'd called around all the pharm chains having to ask what man Continue reading >>
Diabetes Medication Recalled
Ascend Laboratories LLC is recalling 1739 1000-count bottles of Metformin Hydrochloride Tablets, USP 500 mg, due to the presence of foreign tablets. According to the US Food and Drug Administration (FDA) Enforcement Report for the week of December 7, amlodipine tablets were discovered in certain bottles of the prescription type 2 diabetes medication. The recall affects bottles distributed in Alabama, Florida, Georgia, South Carolina, and Tennessee with the following code information: This ongoing recall was first initiated by Ascend Laboratories on November 2. The FDA classified it as a Class II recall on November 29. A Class II recall involves products that might cause a temporary health problem, or pose only a slight threat of a serious nature, according to the FDA Enforcement Report Definitions page. The medication was manufactured by Alkem Laboratories Ltd in Mumbai, India, and distributed by Ascend Laboratories in Montvale, NJ.Meredith Edwards White FDA Approves Treatment for Acute Myeloid Leukemia The US Food and Drug Administration has approved a first-in-class drug for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific mutation. Ivosidenib (Tibsovo; Agios Pharmaceuticals) is the firstIDH1inhibitor approved for the treatment of patients with AML who have theIDH1mutation. The FDA approved ivosidenib for use along with a companion diagnosticthe RealTime IDH1 Assaywhich was approved by the agency on the same day and is specifically designed to detect mutations in theIDH1gene in patients with AML. If the RealTime IDH1 Assay detects theIDH1mutation in the patients blood or bone marrow, that patient may be eligible for treatment with ivosidenib. This approval was based on results from a single-arm clinical trial of 1 Continue reading >>
Prescription Drugs Manufactured By Ascend Laboratories, Llc - Recall Guide
2.1 Important Administration Instructions Cefuroxime axetil tablets and cefuroxime axetil for oral suspension are not bioequivalent and are therefore not substitutable on a milligram-per-milligram basis [see Clinical Pharmacology (12.3)]. Administer cefuroxime axetil tablets as described in the appropriate dosage guidelines [see Dosage and Administration (2.2)]. Administer cefuroxime axetil tablets with or without food. Pediatric patients (aged 13 years and older) who cannot swallow the cefuroxime axetil tablets whole should receive cefuroxime axetil for oral suspension because the tablet has a strong, persistent bitter taste when crushed [see Dosage and Administration (2.2)]. Administer cefuroxime axetil tablets as described in the dosage guidelines table below with or without food. Table 1. Adult Patients and Pediatric Patients Dosage Guidelines for Cefuroxime Axetil Tablets Infection Dosage Duration (Days) Adults and Adolescents (13 years and older) Pharyngitis/tonsillitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis (mild to moderate) 250 mg every 12 hours 10 Acute bacterial exacerbations of chronic bronchitis (mild to moderate) 250 or 500 mg every 12 hours 10 a Secondary bacterial infections of acute bronchitis 250 or 500 mg every 12 hours 5 to 10 Uncomplicated skin and skin-structure infections 250 or 500 mg every 12 hours 10 Uncomplicated urinary tract infections 250 mg every 12 hours 7 to 10 Uncomplicated gonorrhea 1,000 mg Single dose Early Lyme disease 500 mg every 12 hours 20 Pediatric Patients younger than 13 years (who can swallow tablets whole)b Acute bacterial otitis media 250 mg every 12 hours 10 Acute bacterial maxillary sinusitis 250 mg every 12 hours 10 a The safety and effectiveness of cefuroxime axetil administere Continue reading >>
Ndc Code 67877-561-10 Metformin Hcl
All contents of this website are provided on an "as is" and "as available" basis without warranty of any kind. The contents of the National Drug Codes List website are provided for educational purposes only and are not intended in any way as medical advice, medical diagnosis or treatment. Reliance on any information provided by the National Drug Codes List website or other visitors to this website is solely at your own risk. Many of Over the Counter drugs are not reviewed by the FDA but they might be marketed to the public if the product complies with the applicable rules and regulations. The information in this website is intended for healthcare providers and consumers in the United States. The absence of a warning or notice for a given drug or drug combination is not indication that the drug or drug combination are safe, appropriate or effective for any given patient. If you have questions or concerns about the substances you are taking, check with your healthcare provider. If you think you may have a medical emergency, please call your doctor or 911 immediately. Continue reading >>
Dailymed - Metformin Hcl - Metformin Hcl Tablet
Metformin Hydrochloride Tablets USP are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown: Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. Metformin Hydrochloride Tablets USP contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients povidone (K-30), povidone (K-90), pregelatinized starch,and magnesium stearate. In addition, the coating for the tablets contains artificial blackberry flavor, hypromellose and polyethylene glycol. Metformin is an antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Its pharmacologic mechanisms of action are different from other classes of oral antihyperglycemic agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Unlike sulfonylureas, metformin does not produce hypoglycemia in either patients with type 2 diabetes or normal subjects (except in special circumstances, see PRECAUTIONS) and does not cause hyperinsulinemia. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insu Continue reading >>
Dailymed - Metformin Hydrochloride- Metformin Hydrochloride Tablet, Extended Release
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL (see PRECAUTIONS ). Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g. carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided (see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , and PRECAUTIONS ). If metformin-associated lactic acidosis is suspected, immediately discontinue metformin hydrochloride extended release tablets USP and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended (see PRECAUTIONS ). Metformin hydrochloride extended release tablets USP are an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown: Metformin hydrochloride is a Continue reading >>
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Dailymed - Metformin Hydrochloride - Metformin Hydrochloride Tablet, Film Coated
Renal impairmentThe postmarketing metformin-associated lactic acidosis cases primarily occurred in patients with significant renal impairment. The risk of metformin accumulation and metformin-associated lactic acidosis increases with the severity of renal impairment because metformin is substantially excreted by the kidney. Clinical recommendations based upon the patients renal function include (see DOSAGE AND ADMINISTRATION , CLINICAL PHARMACOLOGY ): o Before initiating metformin hydrochloride tablets, obtain an estimated glomerular filtration rate (eGFR) o Metformin hydrochloride tablets are contraindicated in patients with an eGFR less than 30 mL/min/1.73 m2 (see CONTRAINDICATIONS ). o Initiation of metformin hydrochloride tablets is not recommended in patients with eGFR between 30-45 mL/min/1.73 m2. o Obtain an eGFR at least annually in all patients taking metformin hydrochloride tablets. In patients at risk for the development of renal impairment (e.g., the elderly), renal function should be assessed more frequently. o In patients taking metformin hydrochloride tablets whose eGFR falls below 45 mL/min/1.73 m2, assess the benefit and risk of continuing therapy. Drug interactions The concomitant use of metformin hydrochloride tablets with specific drugs may increase the risk of metformin-associated lactic acidosis: those that impair renal function, result in significant hemodynamic change, interfere with acid-base balance, or increase metformin accumulation. Consider more frequent monitoring of patients. Age 65 or greater The risk of metformin-associated lactic acidosis increases with the patients age because elderly patients have a greater likelihood of having hepatic, renal, or cardiac impairment than younger patients. Assess renal function more frequently in elde Continue reading >>
Metformin Smelling Fishy? What You Can Do.
Researchers have discovered what many people with diabetes have known for years: The popular Type 2 diabetes drug metformin (brand names Glumetza, Riomet, Glucophage, Fortamet, and others) has a distinctive scent that, for some people, is enough to cause them to stop taking it. But as the most widely prescribed diabetes drug in the United States, metformin plays an important role in helping people with Type 2 diabetes control their blood glucose levels, and experts have suggested several solutions for dealing with the medicine’s unique scent. In a letter published in the Annals of Internal Medicine, physicians from the Medical College of Georgia described two adult men with Type 2 diabetes who complained of a “dead fish” odor of metformin that had led both men to stop taking the medicine. Searching the medical literature for more information, author J. Russell May, PharmD, and colleagues found no reports of this issue. Upon searching the Internet, however, the researchers came across hundreds of message board posts referencing metformin’s odor, and an informal survey of pharmacists found that many could identify the medicine by its distinct smell. May and his colleagues wrote to the journal to raise awareness of this issue and questioned whether nausea, one of the most commonly reported side effects of metformin, could in some cases in fact be a reaction the fishy odor. May noted that “Metformin is an excellent drug, but the immediate-release formulation may have an odor to it. The smell is fishy or like the inside of an inner tube, and in a patient’s mind…they may think the drug isn’t good.” (A manufacturer of metformin notes that there has been no association between the odor of metformin and its effectiveness.) The authors indicated that switching t Continue reading >>
