Medication Monitor

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  • February 2, 2019

    FDA is warning that CoaguChek XS PT Test Strips used with CoaguChek test meter devices to monitor warfarin levels may provide results that are higher than the actual INR and should not be relied upon to adjust the drug dosage. As a result of incorrect INR results, some patients may be prescribed an insufficient warfarin dose or be instructed to interrupt warfarin use. This may increase the risk for dangerous blood clots.

    FDA classified this action as a Class I recall, the most serious type of recall, which means use of these devices may cause serious injuries or death.

    This recall is related to the November 2018 Roche Diagnostics recall, which is still in effect and involved more than 1.1 million packages that were distributed nationwide from January 12, 2018, to October 29, 2018.

    The test strips were manufactured by Roche but distributed by Terrific Care/Medex Supply. They include catalog numbers that were not in the previous Roche recall because the strips were not labeled or authorized for sale in the United States and were only distributed by Roche outside the country. Terrific Care/Medex Supply purchased the Roche test strips from an unknown source and imported and sold them in the United States.

    Incorrect INR results are of particular concern for individuals at an increased risk of blood clots, including those with mechanical heart valves, those with atrial fibrillation who are at high risk of stroke, or those who had a recent blood clot. It is important to note that problems with the CoaguChek XS PT test strips are not likely to be evident to the patient.

    The test strips are used with the CoaguChek XS plus, CoaguChek XS Pro, CoaguChek XS professional, CoaguChek XS PST, and CoaguChek Vantus test meter devices.

    Patients and health care providers who are using CoaguChek meters should immediately stop using test strips purchased from Terrific Care/Medex Supply and use an alternative test method.

    All health care providers, patients, and caregivers are strongly encouraged to voluntarily report INR test meter problems directly to FDA through MedWatch. Problems should be reported whenever one suspects that there may be an issue with an INR test meter such as a malfunction or incorrect result, or that the meter caused or contributed to a serious injury or death.

    FDA said it will provide updates related to this recall when they are available.

  • February 1, 2019

    Tris Pharma is expanding the scope of its November 2018 recall by adding three additional lots of ibuprofen oral suspension drops, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

    Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from one of the affected lots. There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury. Some units from these six lots have been found to contain ibuprofen as high as 10% above the specified limit. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.

    To date, no serious adverse events have been reported related to this recall.

    The product is used as a pain reliever/fever reducer and is packaged in 0.5-oz. and 1-oz. bottles. The affected lots can be found here.

  • January 11, 2019

    On December 31, 2018, Results RNA announced a voluntary recall of Lubrisine Eye Drops because a recent FDA inspection found the product contains undeclared colloidal silver and was manufactured using practices that do not support its sterility.

    Use of a nonsterile eye drop could result in a potentially sight-threatening eye infection. Exposure to colloidal silver over an extended period of time could result in permanent discoloration of the conjunctiva. The products can be identified by the following label and the lot number located on the bottom of the bottle.

    The product is used to support lubrication of dry eyes and is packaged in a single 1-oz dropper bottle with the UPC code 9238230723. The affected lots include all those manufactured from May 12, 2012, forward. This date of manufacture is located on the bottom of the bottle.

    Lubrisine Eye Drops were distributed worldwide through healthcare practitioners, internet distributors, and the company’s website to wholesale and retail customers.

    Results RNA LLC notified its distributors and customers by e-mail on December 14, 2018, announcing the recall, with specific directions for returning all units and how to obtain a refund. Consumers with Lubrisine Eye Drops should stop using the product immediately.

    As of the announcement date, Results RNA had not received any reports of adverse events or illnesses related to this recall.

  • January 11, 2019

    On December 19, 2018, Terrific Care/Medex Supply Dist. initiated a nationwide recall of Roche CoaguChek test strips distributed directly to U.S. consumers because the products have been found to inaccurately report high INR test results. This recall only includes CoaguChek test strips whose catalog/REF numbers do not end in 160.

    Patients taking warfarin who receive inaccurate INR results above their target therapeutic range may be at risk for inappropriate therapeutic measures, such as a warfarin dose reduction, interruption of warfarin use, or administration of vitamin K.

    This recall is related to the recent Roche Diagnostics Recall, the manufacturer of CoaguChek meters and test strips. The CoaguChek test strips distributed by Terrific Care/Medex Supply Dist include Catalog/REF numbers that were not included in the recent Roche recall because these items were not distributed by Roche Diagnostics in the United States.

  • December 27, 2018

    Asclemed USA is voluntarily recalling 20 lots of Dyural-40 and 61 lots of Dyural-80, to the user level. The products include recalled sodium chloride 0.9% manufactured by Fresenius Kabi, which has been recalled because product labeling incorrectly states that stoppers do not contain latex.

    For the population most at risk, those with a severe allergic reaction to latex, there is probability of an anaphylactic reaction, and this could result in hospitalization or death. To date, Asclemed USA has not received any reports of adverse events related to this recall.

    The products are Dyural-40 convenience kits packaged in plastic trays and Dyural-80 convenience kits packaged in plastic trays, containing sodium cChloride 0.9% by Fresenius Kabi.

    The affected Dyural-40 lots can be found here.