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  • FDA Drug Updates

    FDA New Approvals


    The FDA has approved Brintellix (vortioxetine) to treat adults with major depressive disorder. Brintellix will be available in 5 mg, 10 mg, 15 mg, and 20 mg tablets. Brintellix and other antidepressant drugs have a Boxed Warning and a Medication Guide alerting patients and healthcare professionals that antidepressants can increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment. Brintellix is co-marketed by Takeda Pharmaceuticals and Lundbeck.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm370416.htm


    Purdue Pharma L.P. has announced that the FDA has approved a new 15 mcg/hour dosage strength of Butrans (buprenorphine) Transdermal System CIII. Four strengths of Butrans will now be available: 5, 10, 15, and 20 mcg/hour. Purdue expects to launch Butrans 15 mcg/hour commercially in the United States in October 2013. Butrans is indicated for the management of moderate to severe chronic pain when a continuous, around-the-clock opioid analgesic is needed for an extended period.
    For more information, visit: www.purduepharma.com/news-media/2013/09/purdue-pharma-l-p-receives-fda-approval-for-15-mcghour-dosage-strength-of-butrans-buprenorphine-transdermal-system-ciii


    The FDA has approved Clinolipid (lipid injectable emulsion, USP) for intravenous feeding in adult patients, providing a source of calories and essential fatty acids for adult patients who are unable to eat or drink. Clinolipid was granted a priority review to help alleviate a drug shortage. Clinolipid is a lipid emulsion that contains a mixture of refined olive oil and refined soybean oil. Clinolipid is intended for adults, and like other intravenous lipid emulsions, should be used with caution in patients with preexisting liver disease or liver insufficiency. Clinolipid should not be used in patients with a known hypersensitivity to egg or soybean proteins, or in those with severe disorders of lipid metabolism (hyperlipidemia). Clinolipid is not indicated for use in preterm infants. The product carries a warning in its label about the risk of death in preterm infants after infusion of intravenous lipid emulsions such as Clinolipid. Clinolipid is also not indicated for use in other pediatric patients because it is not known whether the amount of essential fatty acids found in Clinolipid is enough to meet the nutritional needs of children. Clinolipid is marketed by Baxter Healthcare Corporation.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm370740.htm


    The FDA has approved Duavee (conjugated estrogens/bazedoxifene) for women who suffer from moderate-to-severe hot flashes (vasomotor symptoms) associated with menopause and for prevention of osteoporosis after menopause. Duavee is a combination of an estrogen agonist/antagonist (bazedoxifene). The bazedoxifene component of Duavee reduces the risk of endometrial hyperplasia that can occur with the estrogen component of Duavee. Duavee is intended only for postmenopausal women who still have a uterus. Because Duavee contains estrogen, it is being approved with the same Boxed Warning and other Warnings and Precautions that have been approved with estrogen products. Duavee is marketed by Wyeth Pharmaceuticals, Inc. (a subsidiary of Pfizer Inc.).
    For more information, visit: www.fda.gov/Drugs/NewsEvents/ucm370679.htm


    CSL Behring has announced that the FDA has expanded the administration options for Hizentra, Immune Globulin Subcutaneous (Human), 20% Liquid, to include dosing once every two weeks (biweekly) for people diagnosed with primary immunodeficiency (PI). Hizentra received FDA approval in March 2010 as a once weekly immunoglobulin G (IgG) replacement therapy. Self-administered weekly or biweekly, Hizentra delivers consistent levels of IgG to help protect those with PI against infections.
    For more information, visit: www.cslbehring.com/newsroom/Hizentra-Biweekly-Dosing-Approved-by-FDA

    MiniMed 530G with Enlite

    Medtronic, Inc. announced the FDA approval of the MiniMed 530G with Enlite, a breakthrough, first-generation artificial pancreas system with Threshold Suspend automation for people with diabetes. Medtronic's system is the first in the United States that can automatically stop insulin delivery when sensor glucose values reach a preset level and when the patient does not respond to the Threshold Suspend alarm. The MiniMed 530G system was approved for use by people with diabetes ages 16 and older. Medtronic will conduct a post-approval study including children ages two and older. Medtronic will begin ramping up production immediately to prepare for a launch of the MiniMed 530G in the next several weeks.
    For more information, visit: http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=1859361

    Sapien Transcatheter Heart Valve

    The FDA has approved revised labeling for the Sapien Transcatheter Heart Valve (THV), making the device available to an expanded group of patients who have inoperable aortic valve stenosis. The Sapien THV is implanted without opening the chest or heart and does not require a heart-lung machine. The device is compressed into a thin, flexible delivery catheter, inserted into an access point in the body and threaded to the site of the diseased valve. The FDA previously approved the valve for insertion through the femoral artery (transfemoral approach), through the leg, or through the lower tip of the heart (transapical approach). The new labeling removes references to specific access points, now making it available for inoperable patients who need an alternate access point. To support the labeling change, Edwards Lifesciences Corp. submitted data from the Transcatheter Valve Therapy Registry (TVTR) in the United States and THV device registries in Europe, along with data from FDA-approved clinical studies, and peer-reviewed medical journals. The TVTR data came from several thousand procedures performed on patients using an alternative access point and showed no evidence that the device performs differently or has a different benefit-risk profile based on the access point. The manufacturer will continue to use data from the TVTR to study short- and long-term patient outcomes of THV procedures using alternative access sites.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm369510.htm


    Teva Pharmaceutical Industries Ltd. has announced that the FDA has approved Treanda (bendamustine HCI) Injection, a new formulation of the currently approved Treanda (bendamustine HCI) for Injection. This new liquid formulation removes the step of reconstituting lyophilized powder with sterile water prior to adding the medicine to the diluent and administering to a patient. Treanda is indicated for use in patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen, and in patients with chronic lymphocytic leukemia.
    For more information, visit: www.tevapharm.com/Media/News/Pages/2013/1855442.aspx?year=2013&page=1

    UroLift System

    The FDA has authorized the marketing of the UroLift system, the first permanent implant to relieve low or blocked urine flow in men age 50 and older with an enlarged prostate. The FDA reviewed the UroLift system through its de novo classification process, a regulatory pathway for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device. The UroLift System is manufactured by NeoTract Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm368325.htm

    FDA First Time Generic Approvals


    The FDA has approved the first generic version of Xeloda (capecitabine), an oral chemotherapy pill used to treat colorectal cancer that has spread to other parts of the body (metastatic), and metastatic breast cancer. Teva Pharmaceuticals USA has gained FDA approval to market generic capecitabine in 150 and 500 mg strengths.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm368515.htm

    Nitrolingual Pumpspray

    Perrigo Company has announced that it has received final approval for its abbreviated new drug application for nitroglycerin lingual spray, 400 mcg/spray, the generic equivalent to Nitrolingual Pumpspray. Perrigo was awarded 180 days of generic drug exclusivity, as it was the first company to submit an Abbreviated New Drug Application containing a paragraph IV certification. Perrigo has commenced shipment of the product. Nitrolingual Pumpspray (nitroglycerin lingual spray, 400 mcg/spray) is indicated for the acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
    For more information, visit: http://perrigo.investorroom.com/2013-09-23-Perrigo-Announces-FDA-Final-Approval-For-Generic-Version-Of-Nitrolingual-Spray-400-mcg-spray

    Voriconazole for Oral Suspension

    Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. has launched Voriconazole for Oral Suspension, 40 mg/mL, which is the first generic version of Pfizer's Vfend for Oral Suspension. Mylan was the first company to have filed a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV patent certification for Voriconazole for Oral Suspension, 40 mg/mL. The company received final ANDA approval from the FDA for this product and was awarded 180 days of marketing exclusivity.
    For more information, visit: http://files.shareholder.com/downloads/ABEA-2LQZGT/2721546931x0x693859/690a81e7-925f-415c-9d5d-1862ec18c2c6/MYL_News_2013_9_30_General_Releases.pdf

    FDA New Indications

    Botox Cosmetic

    The FDA has approved a new use for Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe lateral canthal lines, known as crow’s feet, in adults. Botox Cosmetic is the only FDA approved drug treatment option for lateral canthal lines. The FDA approved Botox Cosmetic in 2002 for the temporary improvement of glabellar lines (wrinkles between the eyebrows, known as frown lines), in adults. Botox Cosmetic works by keeping muscles from tightening so wrinkles are less prominent. Botox Cosmetic is manufactured by Allergan Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367662.htm


    UCB has announced that the FDA has approved Cimzia (certolizumab pegol) for the treatment of adult patients with active psoriatic arthritis. Cimzia is also approved for the treatment of adults with moderately to severely active rheumatoid arthritis. In addition, it is approved for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. The FDA is also reviewing a filing for Cimzia in the treatment of adults with active axial spondyloarthritis, including patients with ankylosing spondylitis.
    For more information, visit: www.ucb-usa.com/_up/ucb_usa_com/documents/September_2013_Cimzia_PsA_Approval.pdf


    The FDA has granted accelerated approval to Perjeta (pertuzumab) as part of a complete treatment regimen for patients with early stage breast cancer before surgery (neoadjuvant setting). Perjeta is the first FDA-approved drug for the neoadjuvant treatment of breast cancer. Perjeta was approved in 2012 for the treatment of patients with advanced or late-stage (metastatic) HER2-positive breast cancer. Perjeta’s new use is intended for patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer (tumor greater than 2 cm in diameter or with positive lymph nodes) who are at high risk of having their cancer return or spread (metastasize) or of dying from the disease. It is to be used in combination with trastuzumab and other chemotherapy prior to surgery and, depending upon the treatment regimen used, may be followed by chemotherapy after surgery. Perjeta is marketed by Genentech, a member of the Roche Group.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm370393.htm


    Janssen Biotech, Inc., has announced that the FDA has approved Stelara (ustekinumab) alone or in combination with methotrexate for the treatment of adult patients (18 years or older) with active psoriatic arthritis.
    For more information, visit: www.jnj.com/news/all/STELARA-Ustekinumab-Receives-FDA-Approval-To-Treat-Active-Psoriatic-Arthritis

    FDA New Labeling Changes

    Arzerra and Rituxan

    The FDA has approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection. The revised labels also will include additional recommendations for screening, monitoring, and managing patients on these drugs to decrease this risk. The risk of HBV reactivation is already described in the Warnings and Precautions section of the labels for both drugs; however, cases continue to occur, including deaths, prompting the FDA to examine this risk further for current evidence that may aid in recognition and reduction in the risk. HBV reactivation is being added to the existing Boxed Warning of the Rituxan label, and a new Boxed Warning is being created for the Arzerra label to describe the risk. The Warnings and Precautions section also is being revised for each drug to express new recommendations.
    For more information, visit: www.fda.gov/downloads/Drugs/DrugSafety/UCM369436.pdf

    Extended-Release and Long-Acting Opioid Analgesics

    The FDA has announced class-wide safety labeling changes and new postmarket study requirements for all extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain. Given the serious risks of using ER/LA opioids, the class-wide labeling changes, when final, will include important new language to help healthcare professionals tailor their prescribing decisions based on a patient’s individual needs. The updated indication states that ER/LA opioids are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Recognizing that more information is needed to assess the serious risks associated with long-term use of ER/LA opioids, the FDA is requiring the drug companies that make these products to conduct further studies and clinical trials. The FDA is also requiring a new Boxed Warning on ER/LA opioid analgesics to caution that chronic maternal use of these products during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life threatening and require management according to protocols developed by neonatology experts. In addition, the FDA is notifying ER/LA opioid analgesic application holders of the need for changes to the following sections of drug labeling: Dosage and Administration; Warnings and Precautions; Drug Interactions; Use in Specific Populations; Patient Counseling Information; and the Medication Guide. Once the safety labeling changes are finalized, modifications will also be made to the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy, to reflect the updated information.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm367726.htm


    The FDA is warning that an additional analysis shows an increased risk of death when intravenous (IV) Tygacil (tigecycline) is used for FDA-approved uses as well as for non-approved uses. As a result, the FDA has approved a new Boxed Warning about this risk to be added to the Tygacil drug label and updated the Warnings and Precautions and the Adverse Reactions sections. A Boxed Warning is the strongest warning given to a drug. These changes to the Tygacil label are based on an additional analysis that was conducted for FDA-approved uses after issuing a Drug Safety Communication about this safety concern in September 2010. Healthcare professionals should reserve Tygacil for use in situations when alternative treatments are not suitable. Tygacil is FDA-approved to treat complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia. Tygacil is not indicated for treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm369580.htm

    FDA Recalls

    0.25% Bupivacaine HCl Injection

    Hospira, Inc. announced that on July 12, 2013, it initiated a voluntary nationwide recall to the user level for one lot of 0.25% Bupivacaine HCl Injection, USP (2.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1159-02). An expanded recall was issued on August 29, 2013 for one lot of 0.75% Bupivacaine HCl Injection, USP (7.5 mg/mL), 30 mL Single-dose Vial (NDC 0409-1165-02). Both recalls are due to confirmed customer reports of particulate floating and/or embedded in the glass vial. The particulate was identified as stainless steel ranging in size from 542 microns to 1700 microns in lot 18-136-DK (0.25% bupivacaine) and as iron oxide with an average size of 2000 microns in lot 23-338-DK (0.75% bupivacaine). To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Both products are packaged 25 units per carton/50 units per case in glass teartop vials. Lot 18-136-DK was distributed August 2012 through September 2012. Lot 23-338-DK was distributed January 2013 through May 2013. Both lots were distributed nationwide to wholesalers/distributors, hospitals, and pharmacies.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm368401.htm

    1% Lidocaine HCI Injection

    Hospira, Inc. has announced that it has initiated a voluntary nationwide recall of one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 20 mL Multiple-dose Fliptop Vial, NDC 0409-4276-01 Lot 25-090-DK (the lot number may be followed by 01 or 02). This action is due to one confirmed customer report of visible particulate, identified in the primary container, in the form of dark red/black particles. The particulate was identified as oxidized stainless steel. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. The recall is being conducted as a precautionary measure. The root cause has not been determined and is under investigation. Hospira informed customers of the issue in a letter dated September 16, 2013. This lot was distributed March 2013 through June 2013.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm370780.htm

    Dual Luer Lock Caps

    Baxter International Inc. announced today it 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. There have been no reported complaints associated with this issue; however, embolic events may not be easily attributed to such particulate matter. The root cause has been identified and resolved. The FDA has designated this as a Class I recall. Baxter's Dual Luer Lock Cap is used as a protective cap on access ports on medical devices such as stopcocks or IV sets when not in use. Customers should not use product from the two recalled lots and should locate and remove all affected product from their facility. Affected lots were distributed to customers between June 19, 2013 and August 20, 2013. Non-affected lot numbers can continue to be used according to the instructions for use.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm369253.htm

    Emergency Cricothyrotomy Kit

    On August 27, 2013, H&H Medical Corporation initiated a nationwide recall of 6619 units of the H&H Emergency Cricothyrotomy Kit. The product has been found to have the potential for a defective cuff balloon on the provided endotracheal airway. The cuff balloon may be defective due to a very particular set of circumstances (a reduction in package density, a higher than average dose of gamma sterilization, and the occasional slippage of a protective silicon sleeve during shipping used to shield the cuff balloon at the end of the endotracheal airway). To date, no injuries or deaths have been reported to H&H or to the FDA. The product lot number can be identified by a lot number and manufacture label applied at the top opening of the kit. The recalled version of the H&H Emergency Cricothyrotomy Kit was produced between August 16, 2012 and July 29, 2013. Consumers who have product should stop using the product and return them to their original place of purchase for immediate credit. Distributors are instructed to return all recalled items.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370781.htm

    ForeCYTE Breast Health Test and Mammary Aspiration Specimen Cytology Test Device

    Atossa Genetics Inc. has initiated a voluntary recall to remove the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market. Atossa is removing the ForeCYTE Breast Health Test and the MASCT device from the market to address FDA concerns about the current instructions for use (IFU), certain promotional claims used to market these devices, and the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid specimen collection process identified in the current IFU. To date, Atossa is unaware of any adverse incidents or injuries associated with the use of the ForeCYTE Breast Health Test and the MASCT device or the processing method currently identified in the IFU.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370784.htm

    Leiter's Compounding Pharmacy: Bevacizumab and Lidocaine/Phenylephrine

    Leiter's Compounding Pharmacy is voluntarily recalling 3 lots of its sterile products due to concerns of sterility assurance with Front Range Laboratories, Leiter's Compounding Pharmacy's independent testing laboratory. The following products and lot numbers are subject to the nationwide recall: bevacizumab lot No. 08052013@1, expiry 11/03/13; bevacizumab lot No. 08052013@4, expiry 11/03/13; and lidocaine/phenylephrine lot No. 07302013@6, expiry 10/28/13. Leiter's Compounding Pharmacy has not received any reports of adverse events or reports of contamination, but decided to recall the products following a recent inspection by the FDA of Front Range Laboratories. The FDA investigators observed that methods used by the independent laboratory to assess sterility might have resulted in pharmacies receiving inaccurate laboratory test results. The FDA has concerns that results obtained from the laboratory are not reliable. These products were dispensed to healthcare providers between 8/05/13 to 9/02/13 nationwide throughout the United States. Leiter's Compounding Pharmacy is notifying prescribing physicians by first class mail, telephone, and/or email and is arranging for return of all recalled products. Facilities that have product that is being recalled should stop using and return to Leiter's Compounding Pharmacy.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm368012.htm

    Metoclopramide Injection and Ondansetron Injection

    Hospira, Inc. has announced that it initiated a voluntary nationwide recall of one lot of Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL), NDC 0409-3414-01, Lot 28-104-DK and two lots of Ondansetron Injection, USP, 4 mg/2 mL, (2 mg/mL), NDC 0409-4755-03, Lots 29-484-DK and 29-510-DK. This action is due to a confirmed vial defect where glass particulate matter (glass strands) were identified as being affixed to the inside of the vial walls. There is potential for the glass particulates to dislodge into the solution. To date, Hospira has not received reports of any adverse events associated with this issue for these lots. This recall is being conducted as a precautionary measure. Hospira advised customers of this recall in a letter dated September 24, 2013. Hospira has completed an investigation where the root cause findings are attributed to a supplier’s manufacturing glass defect. As a result of this issue, Hospira is working with its supplier on implementing corrective and preventive actions. Metoclopramide Injection, USP, 10 mg/2 mL (5 mg/mL), NDC 0409-3414-01, Lot 28-104-DK (the lot number may be followed by a 01), is packaged in a 2 mL single-dose fliptop vial, with an expiration date of October 1, 2014. Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), NDC 0409-4755-03, Lots 29-484-DK and 29-510-DK (the lot numbers may be followed by a 01) are packaged in a 2 mL single-dose fliptop vial, with an expiration date of May 1, 2015. Both products are packaged as 25 units per carton/100 units per case in glass fliptop vials. The affected lots were distributed nationwide between June 2013 and September 2013 to wholesalers/distributors, hospitals, and pharmacies.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm370658.htm

    Risperdal Consta

    Janssen Pharmaceuticals, Inc. is initiating a voluntary recall of one lot of Risperdal Consta (risperidone) Long-Acting Injection, due to a sterility failure. The affected product should not be administered to patients. The recall will not result in a shortage of the Risperdal Consta 25 mg dosage strength. The lot of Risperdal Consta 25 mg was distributed January 14, 2013 through May 20, 2013.
    For more information, visit: www.janssencns.com/sites/default/files/pdf/risperdal/Risperdal_Consta_Recall_Letter.pdf

    Siemens MicroScan Synergies Plus and MicroScan RapID/S Plus Negative Panels

    MicroScan Synergies plus and MicroScan RapID/S plus Negative Panels are reporting false susceptible and false intermediate results for imipenem and meropenem antimicrobial susceptibility testing when using the MicroScan WalkAway System. This defect may lead to treatment with an inappropriate antibiotic or a delay in initiating appropriate therapy. This recall covers 78,020 panels distributed in the United States between 07/11/2011 and 08/02/2013. Siemens sent an Urgent Field Safety Notice dated August 21, 2013, to all affected customers. The letter identified the defective products, problem, and actions to be taken. The letter instructed customers to suppress all reporting of sensitive and intermediate results for imipenem and meropenem. Siemens also recommends that customers consider the need to review previous test results, conduct patient follow-up, and/or repeat testing. In addition, an Important Product Information notice will be added to products manufactured in future kits.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm367217.htm

    Testosterone Cypionate (Sesame Oil) 200 mg/mL

    Park Compounding is voluntarily recalling one lot of sterile medication Testosterone Cypionate (Sesame Oil) 200 mg/mL Lot #05072013@1 Exp: 11/3/2013 for injection in 10 mL amber vials, to the consumer level. In a recent inspection, FDA investigators observed that methods used by Front Range Laboratories to assess sterility might have resulted in pharmacies receiving inaccurate laboratory test results. The FDA has concerns that results obtained from the laboratory are not reliable. The prescription preparations were sold during May and June of 2013, in the following states: California and Indiana. The products would have been sold directly to customers (pick up and by mail) and to physician offices by prescription (pick up and by mail). To date there have been no reported adverse events associated with the use of these products and there has been no confirmation of lack of sterility of these products. Park Compounding is notifying its customers by phone and mail and is arranging for return of all recalled product lots. Customers that have product that is being recalled should stop using it and contact Park Compounding to arrange for return of unused product.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm367838.htm

    FDA Alerts

    Duragesic Patches

    The FDA is requiring color changes to the writing on Duragesic (fentanyl) pain patches so they can be seen more easily. The FDA continues to learn of deaths from accidental exposure to fentanyl patches. Patients and healthcare professionals are reminded that fentanyl patches are dangerous even after they have been used because they still contain high amounts of strong narcotic pain medicine. In an effort to minimize the risk of accidental exposure to fentanyl patches, the FDA is requiring the manufacturer of Duragesic to print the name and strength of the drug on the patch in long-lasting ink, in a color that is clearly visible to patients and caregivers. The current ink color varies by strength and is not always easy to see. This change is intended to enable patients and caregivers to more easily find patches on patients’ bodies and see patches that have fallen off, which children or pets could accidentally touch or ingest. The manufacturers of generic fentanyl patches are being requested to make similar changes.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm369457.htm

    The Compounding Shop: Budesonide Solution

    The FDA has alerted patients and healthcare providers that budesonide solution, used for nasal irrigation, from The Compounding Shop may be contaminated and should not be used or administered to patients. The FDA observed a 1000 mL bottle of budesonide solution from The Compounding Shop that contained visible, white, floating material. The FDA identified that material as a fungus and is concerned that contamination may be present in other budesonide solution products from The Compounding Shop that may currently be on the market. The FDA is alerting healthcare providers to immediately quarantine any budesonide solution products from The Compounding Shop, and not administer it to patients.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm351326.htm