Medication Monitor

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  • 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.

  • December 27, 2018

    Tris Pharma has voluntarily recalled three lots of Infants’ Ibuprofen Concentrated Oral Suspension, 50 mg per 1.25 mL, to the retail level. The recalled lots may contain higher concentrations of ibuprofen.

    There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury. Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache, and GI bleeding are also possible adverse effects. To date, Tris Pharma has not received any reports of adverse events related to this recall.

    The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. bottles for the recalled lots listed here.

    Tris Pharma sold the affected lots to one customer, which distributed the lots into the U.S. market. Tris Pharma has notified its customer by urgent recall notice and is arranging for return of the recalled product.

  • November 30, 2018

    FDA is warning about genetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication's effects has not been determined. These genetic tests might be offered through health care providers or advertised directly to consumers and claim to provide information on how a patient will respond to medications used to treat conditions such as depression, heart conditions, acid reflux, and others. They might claim to predict which medication should be used or that a specific medication may be less effective or have an increased chance of adverse effects compared with other medications due to genetic variations.

    Results from these tests may also indicate that the health care provider can or should change a patient's medication on the basis of these test results. FDA is also aware of software programs that interpret genetic information from a separate source that claim to provide this same type of information. However, sufficient clinical evidence is not currently available for these genetic tests or software programs, and therefore, these claims are not supported for most medications.

    According to the agency, patients and health care providers should not make changes to a patient's medication regimen on the basis of results from genetic tests that claim to predict a patient's response to specific medications, but are not supported by sufficient scientific or clinical evidence to support this use. Doing so may put the patient at risk for potentially serious health consequences.

    There are a limited number of cases for which at least some evidence does exist to support a correlation between a genetic variant and drug levels within the body, and this is described in the labeling of FDA cleared or approved genetic tests and FDA-approved medications. FDA-authorized labels for these medical products may provide general information on how DNA variations may affect the levels of a medication in a person's body, or they may describe how genetic information can be used to determine therapeutic treatment, depending on the available evidence.

    Recommendations for health care providers and laboratories

    • If you are using, or considering using, a genetic test to predict a patient's response to specific medications, be aware that for most medications, the relationship between DNA variations and the medication's effects has not been established. Check the FDA-approved drug label, or the label of the FDA-cleared or approved genetic test for information regarding whether genetic information should be used for determining therapeutic treatment.
    • If a patient brings you a test report from a genetic test offered directly to consumers that claims to predict a person's response to a specific medication, seek information in the FDA-approved drug label regarding whether genetic information should be used for determining therapeutic treatment.
    • Be aware that there are some FDA-approved drug and genetic test labels, and labels of FDA-cleared genetic tests that provide general information about the impact of DNA variations on drug levels, but do not describe how that genetic information can be used for determining therapeutic treatment. These labels are intended to be informational, but do not indicate that there is sufficient evidence to support making treatment decisions based on the information provided by the genetic test.
    • Know that information regarding therapeutic treatment recommendations for patients with certain genetic variations can be found in the warnings (Boxed Warning, or Warnings and Precautions), Indications and usage, Dosage and Administration, or Use in Specific Populations sections of the FDA approved drug labeling, as appropriate.
    • Be aware that most genetic tests that make claims regarding effects of a specific medication have not been evaluated by FDA.