Amgen Recalls Aranesp Prefilled Syringes in Several Countries Outside of the U.S. Due to the Presence of Visible ParticulatesAugust 14, 2014 9:05 am | News | Comments
Amgen initiated a voluntary recall on June 26, 2014 for nine packaged lots of Aranesp (darbepoetin alfa) (500 mcg) prefilled syringes from non-U.S. distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination.
Regeneca Worldwide a division of VivaCeuticals, Inc. Las Vegas, NV is conducting a voluntary...
Cubist Pharmaceuticals today announced it is voluntarily recalling certain lots of CUBICIN® (...
BMS Issues Voluntary Nationwide Recall of COUMADIN® for Injection Due to Presence of Particulate MatterJune 30, 2014 1:40 pm | News | Comments
Bristol-Myers Squibb Company is voluntarily recalling six lots of COUMADIN® FOR INJECTION, 5 mg...
Doctor’s Best is voluntarily recalling lot 3121005 (7379 bottles) of Red Yeast Rice dietary supplement, 600 mg Capsules, 120-count bottles to the retail level. Red Yeast Rice has been found to contain undeclared lovastatin, a previously approved drug indicated for the treatment of high cholesterol, making this an unapproved new drug.
Alexion Pharmaceuticalstoday announced that it is initiating a voluntary recall of certain lots of Soliris® (eculizumab) 300 mg/30 mL concentrated solution for intravenous infusion that were manufactured using a process component during vial filling identified in the November 2013 recall to the hospital/user level.
Hospira will initiate a voluntary nationwide recall to the user level for one lot of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL) 20 mL Multidose Vial, NDC 0409-2267-20, Lot 36-225-DD, Expiration 12/01/2015. The recall is due to a confirmed customer report of embedded particulate within the glass vial and visible particles floating in the solution.
Cubist Pharmaceuticals is voluntarily recalling one lot of CUBICIN® (daptomycin for injection) to the user level due to the presence of particulate matter, reported via customer complaint and identified as glass particles, found in a single vial from this lot, produced by a contract manufacturer.
Hospira announced today that on April 2, 2014, it informed customers of a nationwide recall of seven lots of Propofol Injectable Emulsion, USP, to the user level due to a glass defect located on the interior neck of the vial, which was identified during a retain sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis
GlaxoSmithKline is recalling the weight loss drug Alli after receiving reports of unknown pills and tablets in the bottles.
Shire is recalling one batch of its Gaucher disease treatment Vpriv because particulate matter was discovered in some vials of the drug.
Pain Free By Nature is recalling "Reumofan Plus" Tablets purchased through their website at www.painfreebynature.com, because they contain undeclared active pharmaceutical ingredients.
The recall is being initiated as a result of complaints of particulate matter, identified as mold, resulting from a leak in the container.
Sagent Pharmaceuticals has announced the voluntary nationwide recall of two lots of Zoledronic Acid Injection due to leaking bags.
Med-Vet International initiated a nationwide recall of 140 boxes of 1/2cc U-40 insulin syringes. The syringes have been found to be labeled with 40 units per 1/2cc syringe and they should be marked with only 20 units per 1/2cc, which potentially could result in lower than prescribed doses of insulin.
Mylan has announced that its subsidiary Agila Specialties Private Limited is conducting a voluntary nationwide recall to the hospital/user level of 10 lots of Etomidate Injection 2 mg/mL - 10 mL and 20 mL.
Merck is recalling a combination cholesterol drug, wiping out the entire U.S. stock, due to packaging defects that could reduce effectiveness. Merck says the recall covers all four dose strengths and every batch distributed since Liptruzet was launched last May.
Baxter International Inc. has initiated a voluntary recall in the United States of two lots of CLINIMIX and one lot of CLINIMIX E Injection parenteral nutrition products to the user level due to complaints of particulate matter found in the products
Abrams Royal Pharmacy is voluntarily recalling all unexpired lots of sterile products dispensed nationwide due to concerns of lack of sterility assurance. All unexpired lots of sterile compounded products are subject to the recall.
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 countries due to a production problem that can affect the strength of the drug. The Danish drug maker says Friday's recall affects certain batches of the prefilled insulin pen NovoMix30 FlexPen.
The FDA posted the notice Tuesday, warning health professionals that the company, a U.S. subsidiary of the German pharmaceutical firm B. Braun Melsungen, has recalled lot H3A7444 of its Cefepime for Injection USP and Dextrose Injection USP. Visible particles were found in a sample from the lot, including specs of metal, cotton fiber and hair.
Baxter International Inc. has initiated a voluntary recall of two lots of its Dual Luer Lock Caps (Product Code 2C6250, Lots 10043 and 10044) because of the presence of loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer Lock Caps may result in thrombotic and embolic events, including: pulmonary embolism, myocardial infarction and stroke.
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.
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