Spectrum Recalls Epinephrine Bulk API Powder

Spectrum Laboratory Products, Inc. is recalling three lots of Epinephrine (L-Adrenaline) USP citing discoloration of the product, the U.S. Food and Drug Administration said.

Epinephrine is a bulk active pharmaceutical ingredient or API used to manufacture or compound prescription products. It is a critical medication that can be used to treat a variety of medical conditions including anaphylaxis and other severe immediate hypersensitivity reactions.

The recall was initiated after complaints from customers who found the product to be discolored.

According to the agency, the use of a finished dose product manufactured or compounded with the 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.

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

However, Spectrum has not received any reports of adverse events related to the recall.

The Epinephrine USP bulk API Powder is packaged in amber glass bottles enclosed in a vacuum sealed pouch in various package sizes. The 1 kg package comes with lot code 1KG0865 and expirey date of 31-Mar-2023.

Further, the 100 gm, 1gm, 25 gm and 5 gm bottles come with lot code 2KL0353 and 2KF0151. The expiry dates are 30-Sep-2023 and 31-Mar-2023.

The affected Epinephrine, USP product can be identified by Spectrum catalog number EP130. The product was distributed directly from Spectrum facilities across the USA and to Canada.

Consumers, distributors, or retail pharmacies that have Epinephrine, USP catalog number EP130, which is being recalled, are urged to stop using the product immediately and return to place of purchase.

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