Federal health officials say that defects in some Medtronic devices used in heart procedures are severe enough that they could cause serious injury or death. The warning covers about 15,000 recalled guidewires, which are inserted through an artery and used to guide other devices into place, such as stents to hold open blocked arteries.
Novo Nordisk is recalling 3 million insulin products used for diabetes treatment in 13 European...
The FDA posted the notice Tuesday, warning health professionals that the company, a U.S....
Baxter International Inc. has initiated a voluntary recall of two lots of its Dual Luer Lock...
University Compounding Pharmacy Recalls Certain Pharmacy Products due to Lack of Assurance of Sterility ConcernsSeptember 9, 2013 8:40 am | News | Comments
In a recent inspection, FDA investigators observed that methods used by the Independent Third Party laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from the laboratory are not reliable.
Altaire Pharmaceuticals Recalls Nine Lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution Sold Under Several BrandsSeptember 9, 2013 8:28 am | News | Comments
Altaire Pharmaceuticals is voluntarily recalling a total of nine lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL, to the consumer level. There have been no reports of adverse effects to consumers so far. However, due to complaints of mold found in the 30 mL bottles after use, concerns regarding the effectiveness of the preservative after use and handling of the product by consumers have prompted the recall.
Johnson & Johnson is recalling 200,000 bottles of Motrin Infants formula due to the risk that they contain tiny plastic particles. J&J's McNeil unit said Friday that the recall affects three lots of its popular Motrin Drops Original Berry Flavor, which is used to lower fever and treat...
Hospira is initiating a voluntary nationwide user-level recall of one lot of Aminosyn™ II 10%, Sulfite-Free, 500mL, NDC 0409-4164-03 Lot 26-138-JT. This action is due to one confirmed customer report where an unknown foreign particle was included in the injection port and in contact with product.
Cubist Pharmaceuticals is voluntarily recalling four lots of CUBICIN® (daptomycin for injection) to the user level due to the presence of particulate matter found in a number of vials from these lots. No adverse events have been reported to date in association with a product complaint of vials containing glass particulates.
The FDA on Sunday announced a recall of all products produced and distributed for sterile use by Specialty Compounding LLC because of concerns about bacterial infections The Cedar Park, Texas, company is recalling all lots of its unexpired sterile compounded medications sold since May 9, including all strengths and dosage forms.
The Food and Drug Administration is warning patients with diabetes about a recall of up to 62 million glucose test strips used to measure blood sugar levels that can show incorrect, abnormally high blood sugar readings. Nova Diabetes Care announced the recall Friday. An incorrect reading could potentially lead to dangerous medication errors for patients.
GNC Holdings Inc. has destroyed 1,542 cases of nutritional supplements in the Pittsburgh area to settle a complaint filed by federal prosecutors.
The American unit of German drugmaker Fresenius is recalling four lots of an injectable drug after finding particles of glass in some vials of the medication. The recall applies to four lots of benztropine mesylate injection, which is used to treat Parkinson's disease and some movement side effects related to epilepsy drugs.
Johnson & Johnson is conducting a voluntary recall of millions of oral contraceptive packages in 43 countries outside the U.S., but says there's a "very low" risk that the flawed tablets could cause unplanned pregnancies. The birth control pills are being recalled — but only from pharmacies...
Amag said its partner Takeda Pharmaceutical is taking a batch of the drug off the market in Switzerland. Amag said four patients experienced severe allergic reactions to the drug, and one of those patients died. That batch was sold only in Switzerland, and the recall doesn't affect any other countries.
Health Canada says three companies are voluntarily recalling all lots of the antipsychotic drug quetiapine. A Health Canada news release says it's due to potential contamination with the antibiotic product clindamycin during the manufacturing process.
A Florida-based compounding pharmacy is voluntarily recalling all lots of its sterile non-expired drug products sold nationwide over concerns the products are not sterile and may contain bacteria, Food and Drug Administration officials said Sunday.
Let’s face it – when you were growing up – perhaps mostly in your teen years – you never really listened to your parents. You might have pretended to, or developed that uncanny ability to not really listen – yet be able to recite the last sentence of whatever was said. A great skill indeed.
ApothéCure, Inc. is voluntarily recalling all lots of sterile products compounded by the pharmacy that are not expired to the user level. The recall is being initiated due to the lack of sterility assurance and concerns associated with the quality control processes.
NuVision Pharmacy is voluntarily recalling all unexpired lots of lyophilized compounds HcG 5000IU-5ml and Sermorelin/GHRH6-5ml to the user level. The recall is being initiated due to a lack of sterility assurance and concerns associated with the quality control processes identified during the FDA inspection.
Green Valley Drugs is voluntarily recalling all lots of all sterile products compounded, repackaged, and distributed by the pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. The recall of sterile products is conducted based on observations of clean room personnel and certain aseptic techniques.
Affirm XL, Inc. is conducting a voluntary recall to the consumer level after FDA lab analysis testing found the product to contain an analogue of sildenafil. Sildenafil is an active ingredient used in an FDA-approved product for the treatment of male Erectile Dysfunction (ED).
A Massachusetts pharmacy issued a voluntary recall Monday of some of its sterile compounding products after "foreign matter" was found in drug vials during an unannounced inspection by state and federal officials. Pallimed Solutions Inc., of Woburn, was also ordered by the state board of pharmacy to stop all sterile compounding activities until further notice.
Johnson & Johnson has announced a voluntary recall for all its OneTouch VerioIQ blood glucose meters in the U.S. because they do not provide a warning when a diabetic's blood sugar level is dangerously high. Instead, the meters turn off. The meters are made by J&J's LifeScan unit, which...
The Food and Drug Administration notified doctors Thursday that a Georgia compounding pharmacy responsible for a drug linked to eye infections has recalled all of its injectable medicines following a federal inspection. Augusta, Ga.-based Clinical Specialties Compounding Pharmacy issued a recall earlier this week on dozens of lots of the Roche drug Avastin after receiving reports of eye infections.
Clinical Specialties is voluntarily recalling All Lots of All Sterile products repackaged and distributed by the pharmacy due to lack of sterility assurance. The recall of all sterile products is conducted in follow-up to concerns regarding practices at the site which cannot assure the sterility of the products.
Shares of Affymax Inc. lost more than half their value Tuesday after the company said it will eliminate 75 percent of its workforce and will consider options including a sale or bankruptcy after its only approved drug was recalled. After the market closed on Monday, Affymax said it will eliminate its commercial and medical affairs organizations, cutting a total of 230 jobs.
Clinical Specialties Issues Voluntary Nationwide Recall of Avastin Unit Dose Syringes due to Potential Serious Eye InfectionMarch 19, 2013 8:09 am | News | Comments
Clinical Specialties is voluntarily recalling Avastin unit dose syringes. The product has or potentially could result in an infection within the eye. Clinical Specialties has received reports of five intra-ocular infections from physician’s office and this is how the problem was identified.
Affymax Inc. shares tumbled in after-hours trading Monday after the biopharmaceutical company said it will cut 75 percent of its workforce following the recall of an anemia drug that caused severe allergic reactions and deaths among some users.
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