Epinephrine recalled due to discoloration

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Epinephrine recall overview: 

• Who: Spectrum Laboratory Products Inc. voluntarily recalled three lots of Epinephrine (L-Adrenaline) USP.
• Why: The product is discolored.
• Where: The epinephrine recall is active in the United States and Canada.

Spectrum Laboratory Products Inc. recalled three lots of Epinephrine (L-Adrenaline) USP in the United States and Canada as customers have complained that the product is discolored. 

The U.S. Food & Drug Administration (FDA) website posted the epinephrine recall Jan. 9.

Epinephrine (L-Adrenaline) USP is a bulk active pharmaceutical ingredient used to manufacture or compound prescription products, the recall states. 

Spectrum says epinephrine is a critical medication used during life-threatening conditions. 

“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 epinephrine recall states.

Treatment with a less-effective product, essentially underdosing epinephrine, could result in death, the recall says.

Spectrum has not received any reports of adverse events related to this recall, so far. It is not facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes lead to class action lawsuits.

Epinephrine used in multiple medicines, according to recall

“Epinephrine (L-Adrenaline) USP bulk API Powder is used in manufacturing and compounding of finished dose epinephrine prescription products” that can be used to treat a number of medical conditions, the recall states.

The recalled product is packaged in amber glass bottles enclosed in a vacuum-sealed pouch, and the affected lot numbers can be seen here. 

The product was distributed directly from Spectrum facilities nationwide in the United States and to Canada.

Spectrum says it is notifying its distributors and customers by certified mail, email and phone and arranging for return of all recalled products. 

“Consumers, distributors or retail pharmacies that have Epinephrine, USP catalog number EP130, which is being recalled, should stop use immediately and return to place of purchase,” the epinephrine recall states.

Similarly, last year, Adamis Pharmaceuticals Corp. recalled certain lots of its SYMJEPI (epinephrine), a potentially life-saving injection used to treat allergic reactions and anaphylactic shock, due to several reports of the syringe clogging. 

Are you affected by the epinephrine recall? Let us know in the comments.

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