The U.S. Food and Drug Administration (FDA) announced the recall of three epinephrine lots, used to treat severe allergic reactions, after consumer complaints.
According to an announcement, manufacturer Spectrum Laboratory Products said it voluntarily recalled the lots after the product was found to be discolored.
Epinephrine, known as L-adrenaline USP, is a bulk active pharmaceutical ingredient that can “treat a variety of medical conditions including anaphylaxis and other severe immediate hypersensitivity reactions, asthma, bronchospasm, airway edema, nasal congestion, dilation during intraocular surgery, vasoconstrictor with local anesthetics, hypotension or shock, heart failure, bradycardia or atrioventricular block, and sudden cardiac arrest,” the announcement said.
Epinephrine is placed in autoinjectors, the most common of which are sold under the EpiPen brand name. They’re often used for people who have severe food allergies or asthma.
Consumers, distributors, or pharmacies that have epinephrine USP with the catalog number EP130 should immediately stop using the product and return it to the place of purchase, said the announcement. It was distributed from Spectrum facilities in the United States and Canada.
“The use of a finished dose product manufactured or compounded with this recalled 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,” the recall bulletin also said. “Treatment with a less-effective product, essentially underdosing epinephrine, could result in death.”
But Spectrum said it has not received any reports of adverse events related to the recall. The company said it is now notifying its distributors and customers through mail, email, and phone and will arrange for the return of the impacted products.
And in October, another drug company, Aurobindo Pharma USA, said it would voluntarily recall two lots of blood pressure medication due to the same impurity. The New Jersey-based firm initiated the recall of quinapril and hydrochlorothiazide in 20 milligram and 12.5 milligram tablets due to the presence of the chemical, which is associated with a higher risk of cancer. Like Lupin, Aurobindo said it did not receive any reports of adverse incidents associated with the medication.