USFDA Warns of Mix-Ups After Reports of Wrong Epinephrine Injections
USFDA Warning
New Delhi: The United States Food and Drug Administration (USFDA) issued a critical warning to health care professionals about the risks associated with unapproved epinephrine nasal solutions manufactured by BPI Labs LLC, located in Largo, Florida, and Endo USA, based in Malvern, Pennsylvania.
According to the FDA, these products have been confused with FDA-approved injectable epinephrine due to "similarities of the bottle and packaging labels between the nasal product and the sterile injectable," leading to incidents where the nasal solution was mistakenly injected.
The agency emphasized that nasal solutions "are not required to be sterile," unlike injectable drugs, and injecting a non-sterile product can cause infections that "may be life-threatening for certain patients." Both the nasal and injectable products are used in health care settings, increasing the potential for dangerous mix-ups.
Endo USA voluntarily recalled its unapproved Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP) on December 20, 2024, following FDA recommendations. However, BPI Labs has not acted to remove its unapproved EPINEPHrine Nasal Solution from the market, despite repeated advisories from the FDA beginning December 12, 2024. The agency continues to receive adverse event reports, with over 25 cases recorded since 2016. A recent report in 2024 detailed an incident where a patient was injected with the nasal solution instead of the injectable product.
The FDA encourages health care professionals and patients to report adverse events or quality issues related to these products through its MedWatch Adverse Event Reporting program. For more details, visit the FDA’s official website.
