Medication Monitor



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  • June 13, 2011

    Bedford Laboratories initiated a nationwide voluntary recall of indomethacin for injection, 1 mg single dose vial, Lot #1948138, Expiration Date September 2011, NDC #55390-299-01. This voluntary recall was initiated because some of the vials in this lot number may contain particulate matter. Out-of-specification results were obtained for particulate matter ≥ 10 micron. The product did meet specification for particulate matter ≥ 25 micron. The particulate matter has been identified as active drug substance and not foreign material or contamination. The product was distributed to wholesalers and distributors nationwide.

      

  • June 10, 2011

    FDA has approved Merck’s redesigned drug container labels that were developed under Merck’s Label Standardization Project. The labels will include a new standardized format to improve readability and provide better information on product and strength differentiation. The project includes the revision of 34 container labels for 16 oral products. The drugs affected include Cozaar, Crixivan, Hyzaar, Isentress, Janumet, Januvia, Mevacor, Noroxin, Prinivil, Prinizide, Propecia, Proscar, Singulair, Zocor, and Zolinza.

     

  • June 9, 2011

    FDA is alerting health care providers that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor class of drugs has been revised to include new safety information about an increased risk of being diagnosed with a high-grade prostate cancer. Data from the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) showed an increased incidence of high-grade prostate cancer with use of finasteride 5 mg/d for 7 years and dutasteride 0.5 mg/d for 4 years.

     

  • June 9, 2011

    Simvastatin dosage restrictions have been announced by FDA, along with additional contraindications concerning use of the drug with certain other medications or above certain doses with other drugs. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of myopathy, FDA said. Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug, the agency added. FDA said simvastatin should never be used with posaconazole, and it moved three drugs from a "do not exceed simvastatin 10 mg" category to an absolute contraindication (gemfibrozil, cyclosporine, and danazol). Dosing limits for simvastain were lowered for amiodaraone, verapamil, and diltiazem (now 10 mg daily) and added for amlodipine and ranolazine (Ranexa—Gilead) (20 mg daily).

  • June 5, 2011

    FDA issued an alert that SimplyThick should not be given to premature infants because the product may cause necrotizing enterocolitis (NEC). Specifically, SimplyThick should not be given to infants born before 37 weeks' gestation who are currently receiving hospital care or have been discharged from the hospital within the past 30 days. The agency is currenlty aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula products.

    On June 4, SimplyThick voluntarily recalled its thickening gel product manufactured at its Stone Mountain, GA, plant. SimplyThick's recall of this product is a result of the company's failure to ensure that harmful bacteria of possible public health significance were destroyed in the manufacturing process at that manufacturing plant. Product manufactured at other facilities remains on the market.

     

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