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# FDA Warns About Dosing Errors with Compounded Injectables
- URL: https://www.fdaweb.com/fda-warns-about-dosing-errors-with-compounded-injectables/
- Published: 2018-10-01T12:00:00.000Z
- Updated: 2026-09-15T00:35:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142478

FDA says it 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,” an [agency notice](https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm621769.htm?ref=fdaweb.com) says. It says two MedWatch reports were received concerning medication errors associated with overdoses of compounded injectable products. For example, one report said that a patient was prescribed 50 mcg of fentanyl. 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 agency says.

  
Additionally, FDA says it has received multiple complaints raising concerns that displaying the strength per milliliter in larger, more prominent font, instead of the strength per total volume, may lead to confusion about how much drug is in the container. A new safety alert directs firms to refer to a 2013 guidance “[Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM349009.pdf?ref=fdaweb.com),” which recommends that “\[f\]or small volume parenteral products, the strength per total volume should be the primary and prominent expression on the principal display panel of the label, followed in close proximity by strength per milliliter enclosed by parentheses.”