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Since 2018, the United States Food and Drug Administration (FDA) and other regulators have found N-nitrosodimethylamine (NDMA) in several sartan- and ranitidine-based drug substances and products (1,2), resulting in widespread [...]

With curtailed on-site inspection activities for manufacturing facilities in the past year as a result of the COVID-19 pandemic, regulatory authorities such as FDA have had a challenging time. However, [...]

Nitrosamines are a group of genotoxic compounds that have been studied widely in the food, water treatment, and chemical industries. In fact, the compound N-Nitrosodimethylamine (NDMA, also known as dimethylnitrosoamine) [...]

Investigations, deviations, complaints, and laboratory investigations are critical to assessing the compliance of a company's quality systems. Deficiencies in the timeliness and thoroughness of these investigations can jeopardize a company's [...]

For the past 10 years, the US Food and Drug Administration has campaigned for a more efficient, risk-based approach to monitoring drug-manufacturing activities. The agency's goal has been to encourage [...]

The pharmaceutical and medical device industries can learn from Toyota's recalls to avoid their own 'runaway' quality problems. The same quality problems that surfaced during the recall of nearly eight [...]

This article provides an overview of the drug Recall Root Cause Research (RRCR) project, an initiative of the US Food and Drug Administration's Center for Drug Evaluation and Research. The [...]

As imaging centers convert their workflow to capitalize on the benefits of digital mammography, some radiologists are concerned about the possibility of an increase in the number of patients recalled. [...]

After an estimated $1 billion spent to develop a drug called torcetrapib that raised HDL cholesterol levels, the manufacturer Pfizer halted its phase 3 clinical trial and suspended development of [...]

Lenoir, NC -- Cytosol Ophthalmics, whose balanced salt solution (BSS) product, Endosol, was implicated in an outbreak last fall of toxic anterior segment syndrome (TASS), is selling off its assets [...]

Washington, DC -- The FDA and Ligand Pharmaceuticals Inc. are warning of the risk for visual loss associated with the use of denileukin diftitox injection (Ontak), a drug used in [...]

Hanford Pharmaceuticals and FDA notified healthcare professionals about the recall of 4 lots of cefazolin for injection 1 g/10 mL vials. Certain lots of the active ingredient used to manufacture [...]

The Institute for Safe Medication Practices and ECRI, a medical device safety research company, are investigating a potentially dangerous problem with smart infusion pumps programming pads. 'We have received reports [...]

The FDA has issued an alert for health professionals and patients regarding complaints of small cracks found at the base of the plastic tip applicator of the 10- and 20-mg [...]

East Hanover, NJ -- Novartis Ophthalmics has recalled seven lots of two GenTeal products in the United States, and 15 lots of two GenTeal products in Canada, over concerns that [...]

Baxter Healthcare Corp. has received a second Food & Drug Administration Class 1 recall in less than four months for its Colleague Volumetric Infusion Pumps. The FDA's Sept. 19 recall [...]

The problem of serious physical risks associated with medications is not going away. Consider the following recent drug recalls: Vioxx (rofecoxib, Merck), Bextra (valdecoxib, Pfizer), and Tysabri (natalizumab, Biogen Idec). [...]

Merck & Co., which last year announced the immediate and voluntary withdrawal of Vioxx (rofecoxib), has informed pharmacists that in order to be eligible for reimbursement of returned Vioxx, all [...]

The Perrigo Company has initiated a voluntary nationwide recall of all lots of concentrated infants' oral drops that are packaged with a dosing syringe bearing only a 1.6-mL mark containing [...]

Purdue Pharma L.P. has been asked by the FDA to remove Palladone (hydromorphone HCl) extended-release capsules from the market after acquiring new information that serious and potentially fatal adverse reactions [...]

The objective of this study was to track the utilization of anti-inflammatory drugs among patients with active rofecoxib prescriptions at the time of market withdrawal through retrospective analysis of pharmacy [...]

Following the voluntary withdrawal of rofecoxib in September 2004 and the subsequent FDA-requested withdrawal of valdecoxib in April 2005, formulary decision-makers are considering options in navigating the changing pain management [...]

AED20 (automatic external defibrillators) that were manufactured between February and July of 2004 have been recalled. The AED20 may display a 'Defib Comm' error message during use, resulting in a [...]

LifeScan is initiating a worldwide notification to all users of its OneTouch Ultra, InDuo, and OneTouch FastTake meters that it may be possible for users to misinterpret their test results. [...]

Methylin CT (methylphenidate HCl), 5-mg chewable tablets indicated for attention deficit hyperactivity disorder and narcolepsy, has been voluntarily recalled. First, one lot was involved because it might contain up to [...]

Tysabri (natalizumab), approved for multiple sclerosis, has had its marketing suspended due to 2 adverse events reported with its use. The FDA received reports of 1 confirmed fatal case and [...]

The FDA requested that Pfizer, Inc. voluntarily withdraw Bextra (valdecoxib) from the market on April 7, 2005, after concluding that the drug's overall risk versus benefit profile is unfavorable. The [...]

The FDA announced that albuterol metered-dose inhalers (MDIs) using chlorofluorocarbon (CFC) propellants may no longer be produced, marketed, or sold in the United States after Dec. 31, 2008. In a [...]

Avastin (bevacizumab) was the subject of a warning letter from the FDA and Genentech about evidence of an increased risk of serious arterial thromboembolic events including cerebrovascular accident, MI, transient [...]

Bextra (valdecoxib), a cyclooxygenase (COX)-2 selective inhibitor for the treatment of osteoarthritis, rheumatoid arthritis, and dysmenorrhea will receive a boxed warning on its label that strengthens previous warnings about the [...]

Albany, OR -- Alternative Health & Herbs Remedies is conducting a voluntary recall of all lots of four American Health & Herbs Ministry-brand eye rinse products following an FDA ruling [...]

Live Eyewear is expanding its Cocoons collection of over-prescription eyewear with scratch-resistant, clear polycarbonate lenses for eye protection after the sun goes down. The 1.2-mm lenses offer complete protection from [...]

Drug warnings and recalls Humira (adalimumab), used in the treatment of rheumatoid arthritis, will receive a label change to reflect a warning regarding the combined use of adalimumab and Kineret [...]

The manufacturer of intravenous pantoprazole (Protonix IV, Wyeth) issued a 'Dear Health Care Professional' letter regarding reports of glass vial breakage with the drug during attempts to connect the vials [...]

When Merck recently recalled Vioxx (rofecoxib), the Familymeds chain was able to call thousands of patients using Silverlink's interactive voice technology. With 80 professional pharmacies in 14 states, Familymeds was [...]

Merck & Co's worldwide withdrawal of rofecoxib (Vioxx) due to an increased risk of serious cardiovascular events after 18 months of chronic use has raised questions among formulary decision-makers regarding [...]

American Pharmaceutical Partners, Schaumberg, Ill., (847) 969-2700, is bringing dimenhydrinate injection back onto the market. Shortage of the drug was followed by its discontinuance for two years. The antiemetic, a [...]

Children's Motrin grape chewable tablets (ibuprofen) has one manufacturing lot (Lot # JAM108, exp 1/06) that may mistakenly contain Tylenol 8 Hour Extended Release Geltabs (acetaminophen). This higher dosage of [...]

FPP of Cincinnati recently recalled 67 bottles with labeling for olanzapine (Zyprexa, Eli Lilly) because they are counterfeit. The recall pertains to 60-count bottles on which the label claims the [...]

Manufacturer recalls Natureplex eye drops; FDA cites non-sterile conditions Natureplex LLC, of Memphis, TN, is recalling 500,000 bottles of Natureplex brand eye-drop products that FDA inspectors said were not manufactured [...]

Becton, Dickinson & Co. (BD) announced that it is initiating a voluntary product recall of certain lots of its BD Test Strips used for blood glucose monitoring. A list of [...]

Monrovia, CA -- Officials at STAAR Surgical Co. are scrambling to answer questions raised by a warning letter from the FDA that criticized the company for failing to review product [...]

The FDA Center for Devices and Radiological Health posted a Class I recall notice for CoaguChek PT test strips. Some of the foil pouches in which the test strips are [...]

Fort Worth, TX -- A software glitch is forcing the recall of 157 LADARWave CustomCornea units produced by Alcon Inc. The error, in the aberrometer of software version 7.91, could [...]

Becton, Dickinson and Company has recalled the ProbeTec ET, an in vitro diagnostic device for the detection of Chlamydia trachomatis and gonorrhea. A component of the device was incorrectly installed [...]

Bausch & Lomb, Rochester, N.Y., (585) 338-6000, has received FDA approval for a generic formulation of Allergan Inc.'s previously discontinued Alphagan 0.2% solution. Bausch & Lomb's brimonidine tartrate ophthalmic solution, [...]

Levaquin (levofloxacin) has been approved by the FDA for the treatment of chronic bacterial prostatitis caused by Escherichia coli, Enterococcus faecalis, or Staphylococcus epidermidis. Counterfeit Lipitor (atorvastatin) continues to be [...]

Atlanta--CIBA Vision is recalling all of its Glitter Eyes contact lenses after it discovered that layers of the lens can partially 'delaminate' and cause pigments within the lens to smear, [...]

Three lots of Lipitor (atorvastatin, Pfizer) are being recalled for fear they are counterfeit and could pose a danger to patients. The recall applies only to bottles that state 'Repackaged [...]

A jury in Corpus Christi, Texas, has ruled that Bayer acted responsibly in the development, marketing, and voluntary withdrawal of Baycol, the company reports. Bayer will now turn its attention [...]