The U.S. Food and Drug Administration has received reports of dosing errors and confusion with the labeled strength expression for certain compounded injectable products. Conventional manufacturers label their injectable products with the strength per
total volume as the primary and prominent expression of strength on the label, whereas some compounders label their injectable products differently. Below is a description of the case reports received by FDA. The case reports illustrate how differences
in the product labels of conventional manufacturers and compounders may lead to dosing errors.
Case Reports
FDA received two MedWatch reports concerning medication errors associated with overdoses of compounded injectable products. In the first report, a patient was prescribed 50 mcg of fentanyl. The product administered to the patient was compounded by an
undisclosed facility location owned by Central Admixture Pharmacy Services. According to the report, the fentanyl IV bag was labeled with the strength per milliliter (50 mcg/mL) in large font and the strength per total volume (2,500 mcg/50 mL) below
in smaller font. The patient was inadvertently administered 2,500 mcg of fentanyl (equivalent to 50 times their prescribed dose). The report noted that the cause of the error was attributed to the prominently stated 50 mcg/mL strength, which was misunderstood
as the total amount of fentanyl in the bag.
In the second report, a patient was prescribed 5 to 10 mg of ketamine as needed for pain. The ketamine injection administered to the patient was compounded by QuVa Pharma, Inc., located in Sugar Land, Texas. According to the report, the product was labeled
as Ketamine HCl 10mg/mL highlighted in yellowThe strength per total volume in the syringe was printed beneath the highlighted text in smaller font (see Fig. 1). The patient inadvertently received 50 mg of ketamine (equivalent to 5 to 10 times their
prescribed dose) and became somnolent (abnormally drowsy). The report noted that the cause of the error was attributed to the prominently stated 10 mg/mL strength, which was misunderstood as the total amount of ketamine in the syringe.
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