Medication Monitor



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Generic Name (Trade Name—Company)
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  • June 12, 2019

    Norvartis is voluntarily recalling three lots (8H57901589, 9H57900189, and 9H57900289) of eltrombopag 12.5 mg for oral suspension to the consumer level because of a risk of potential peanut flour contamination.

    Eltrombopag 12.5 mg for oral suspension is indicated for treatment of chronic immune thrombocytopenia, hepatitis C-associated thrombocytopenia, and severe aplastic anemia in certain adult and pediatric patients who have not received prior immunosuppressive therapy or had an insufficient response to immunosuppressive therapy.

    Eltrombopag tablets in 12.5-, 25-, 50-, and 75-mg strengths are not affected by this recall and are not manufactured in the same facility.

    Eltrombopag 12.5 mg for oral suspension was distributed nationwide through specialty pharmacies.

    To date, Novartis has not received any reports or adverse events for this recall.

  • June 12, 2019

    Par Pharmaceutical is voluntarily recalling one lot of mycophenolate mofetil for injection, USP, to the hospital and retail pharmacy level. One vial of product was observed containing a glass fragment after reconstitution.

    Administration of a glass particulate, if present in an I.V. drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. 

    Mycophenolate mofetil for injection, USP, is indicated for prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants. It should be used concomitantly with cyclosporine and corticosteroids.

    The affected product includes lot AD812, expiry 09/2020. It is packaged in cartons of four single-use vials labeled NDC 42023-172-04 and was distributed nationwide in the United States between January 23, 2019, and February 11, 2019.

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

  • June 12, 2019

    In a May 2, 2019, statement, FDA indicated that several compounding pharmacies and physicians had contacted the agency to determine if compounders can use the bulk drug substance oxitriptan to compound oral drugs under section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for an identified patient with tetrahydrobiopterin (BH4) deficiency, a group of rare inborn errors of metabolism.

    The agency has informed these stakeholders that it does not intend to object to the compounding of oral oxitriptan for patients with BH4 deficiency who have a prescription identifying the disorder, as long as the drug is compounded in compliance with all other conditions of section 503A of the FD&C Act.

    This group of disorders is also identified by the names primary tetrahydrobiopterin (BH4) deficiency, atypical phenylketonuria (PKU), or BH4-deficient hyperphenylalaninemia. Patients with 6-pyruvoyl-tetrahydropterin synthase (6-PTPS) deficiency are among those included in this group of disorders.

    On February 19, 2019, FDA issued a final rule that placed six bulk drug substances on the list of bulk drug substances that can be used in compounding under section 503A of the FD&C Act (referred to as the “503A bulks list”) and identified four others, including oxitriptan, that FDA did not place on the 503A bulks list. FDA evaluated oxitriptan, also known as 5-hydroxytryptophan or 5-HTP, for inclusion on the 503A bulks list as a treatment for depression or insomnia and did not include it on the list.

    Patients with BH4 deficiency who have questions should contact their health care provider or contact FDA via druginfo@fda.hhs.gov. Health professionals and compounders with questions about using the bulk drug substance oxitriptan to compound oral drugs for BH4 deficiency under section 503A of the FD&C Act should contact compounding@fda.hhs.gov.

  • May 2, 2019

    Sagent Pharmaceuticals announced a voluntary nationwide recall of one lot (#M813513) of ketorolac tromethamine injection USP 60 mg/2 mL (30 mg per mL) because microbial growth was detected during a routine simulation of the manufacturing process. This product was manufactured by Zydus (Cadila Healthcare Limited) and distributed by Sagent. 

    Adult patients administered the product intravenously are at most risk of a serious bloodstream infection of sepsis. The possibility of a breach in sterility assurance in distributed product, while remote, cannot be eliminated. No batches of distributed product have been identified as actually containing microorganisms. To date, Sagent has not received reports of any adverse events associated with this issue.

    The product is a NSAID indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. It is supplied in 2-ml glass tubular vials. The lot number being recalled was distributed to hospitals, wholesalers, and distributors nationwide from January to March 2019.

  • May 1, 2019

    FDA is warning that rare but serious injuries have happened with certain common prescription insomnia medicines because of sleep behaviors, including sleepwalking, sleep driving, and engaging in other activities while not fully awake. These complex sleep behaviors have also resulted in deaths. These behaviors appear to be more common with eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) than with other prescription medicines used for sleep.

    If patients experience a complex sleep behavior during which they engage in activities while they are not fully awake, or do not remember activities they have done while taking the medicine, they should stop taking their insomnia medication and contact their health professional right away.

    Health professionals should not prescribe eszopiclone, zaleplon, or zolpidem to patients who have previously experienced complex sleep behaviors after taking any of these medicines. Health professionals should advise all patients that although rare, the behaviors caused by these medicines have led to serious injuries or death, and they should discontinue taking these medicines if they experience an episode of complex sleep behavior.

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