Medication Monitor



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Generic Name (Trade Name—Company)
Notes
  • August 1, 2019

    On July 15, Legacy Pharmaceutical expanded its consumer-level recall of three repackaged lots of losartan tablets 50 mg (NDC 68645-494-54) to include one additional lot. This recall was prompted by Torrent Pharmaceuticals's nationwide recall of losartan tablets, which were found to contain trace amounts of N-nitroso N-methyl 4-amino butyric acid (NMBA), a potential human carcinogen. 

    The product is used to treat high blood pressure and congestive heart failure and is packaged in 30-count bottles.

    The affected losartan includes four repackaged lots numbers (three initial repackaged lots and one expanded repackaged lot): 180190, 180191, 181597, and 181598.

    To date, Legacy has not received any reports of adverse events related to this recall.

  • August 1, 2019

    On July 23, Jubilant Cadista Pharmaceuticals announced a recall of one lot (#183222) of drospirenone and ethinyl estradiol tablets, USP, 3 mg/ 0.02 mg, 28 x 3 blister pack/carton to the consumer level. The affected product is being recalled because of out-of-specification (OOS) dissolution results at the 3-month stability time point. OOS dissolution may decrease product efficacy.

    The recalled product is packaged in a carton with three blister cards, each containing 28-film coated, biconvex tablets, in the following order: 24 active pink, round, unscored, film-coated tablets debossed with a “20” on one side, each containing 3 mg drospirenone and 0.02 mg ethinyl estradiol,  and four inert white, round, unscored, film-coated tablets debossed with a “PL.”

    To date, Jubilant Cadista Pharmaceuticals has not received any reports of adverse events related to this recall.

  • August 1, 2019

    On July 15, Alvogen announced a recall of two lots (#180060 and #180073) of Fentanyl Transdermal System 12 mcg/h transdermal patches because a small number of cartons contained 50 mcg/h patches. The 50 mcg/h patches that were included in cartons labeled 12 mcg/h are individually labeled as 50 mcg/h. This transdermal system is manufactured by 3M Drug Delivery Systems, St. Paul, MN.

    Application of a 50 mcg/h patch instead of a prescribed 12 mcg/h patch could result in serious, life-threatening, or fatal respiratory depression. Groups at potential increased risk could include first-time recipients of such patches, children, and older adults. To date, Alvogen has not received any reports of adverse events related to this issue.

    The product is indicated for management of pain in opioid-tolerant patients and is packaged in primary cartons of five individually wrapped and labeled pouches.

  • July 31, 2019

    FDA has approved new warnings about an increased risk of blood clots and of death with the 10-mg twice-daily dose of tofacitinib (Xeljanz, Xeljanz XR) for treatment of ulcerative colitis. In addition, the approved use of tofacitinib for ulcerative colitis will be limited to certain patients who are not treated effectively or who experience severe adverse effects with certain other medicatuibs.

    FDA approved these changes, including adding its most prominent boxed warning, after reviewing interim data from an ongoing safety clinical trial of tofacitinib in patients with rheumatoid arthritis (RA) that examined a lower and this higher dose of the medication.

    The 10-mg twice-daily dose of tofacitinib is not approved for RA or psoriatic arthritis (PsA). This dose is only approved for ulcerative colitis for initial treatment and for long-term use in limited situations. While the increased risks of blood clots and of death were seen in patients taking this dose for RA, these risks may also apply to those taking tofacitinib for ulcerative colitis.

    Tofacitinib was first approved in 2012 to treat adult patients with RA who did not respond well to methotrexate. In 2017, FDA approved the drug to treat patients with PsA who did not respond well to methotrexate or other similar medications. In 2018, FDA approved tofacitinib to treat ulcerative colitis.

    Health professionals should discontinue tofacitinib and promptly evaluate patients who have symptoms of thrombosis. Counsel patients about the risks, and advise them to seek medical attention immediately if they experience any unusual symptoms, including sudden shortness of breath, chest pain that worsens with breathing, swelling of a leg or arm, leg pain or tenderness, or red or discolored skin in the painful or swollen leg or arm.

    Tofacitinib should be reserved for treatment of ulcerative colitis in patients who experienced treatment failure with tumor necrosis factor (TNF) blockers or could not tolerate them. Patients with a higher risk of thrombosis should not use the agent. For treatment of ulcerative colitis, tofacitinib should be used at the lowest effective dose, and the 10-mg twice daily dosage limited to the shortest duration needed.

  • July 24, 2019

    Bayer is voluntarily recalling two lots (27118RK and 27119CG) of Kogenate FS antihemophilic factor (recombinant) 2000 IU vials in the United States to the patient level. Certain vials from these two lots that were labeled as Kogenate FS actually contain the FVIII hemophilia A treatment Jivi antihemophilic factor (recombinant) PEGylated-aucl 3000 IU.

    The affected lots were distributed from February 5, 2019, to July 15, 2019, from Bayer’s distribution sites in Berkeley, CA and Shawnee, KS.

    While the majority of the mislabeled vials in the affected lots were recovered, approximately 990 of these vials were released in the United States. The associated Jivi batch was expired as of August 2018. However, all stability specifications of this expired Jivi batch had continued to be met as of April 2019.

    The United States is the only country where affected products were distributed. Bayer said it is working closely with FDA to manage the recall and to minimize disruption to supply and inconvenience to patients. 

     

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