Spectrum Laboratory Products issued a voluntary recall of three lots of bulk compound epinephrine in the wake of customer complaints of discoloration.
The FDA posted the company's recall letter Monday. The product pull covers bulk active pharmaceutical ingredient that was distributed across the U.S. and Canada. The affected lots are 1KG0865, 2KL0353 and 2KF0151.
To date, the company said, there have been no reports of adverse events related to the recall.
Epinephrine is typically used to treat severe allergic reactions (including anaphylaxis) to insect bites or stings, medicines, foods or other substances. Additionally, it can be used to treat anaphylaxis caused by asthma, bronchospasm, airway edema and more.
The company warned that use of a finished dose of the compounded product “could result in less-effective product, and incomplete treatment of life-threatening conditions including low blood pressure, heart failure, anaphylaxis, irregular heartbeat, and heart attack.”
Spectrum also warned that a less-effective dose could result in death.