Spectrum Epinephrine Bulk API Powder recall: Reason, lots affected, and all you need to know

Spectrum Laboratory Products, Inc. has issued a nationwide recall for three lots of Spectrum Epinephrine (L-Adrenaline) USP over discoloration concerns. The affected pharmaceuticals may pose mild to severe health risks when administered to a patient.

The voluntary recall was initiated after the company received consumer complaints stating that the Epinephrine (L-Adrenaline) USP drug showed signs of discoloration. The products under the recall fall in the category of Powders for injection (PIs) drugs and are distributed in 'powder' form in vials.

Any Powder for Injection (PIs) drug that shows signs of discoloration loses its effectiveness and can pose life-threatening risks when administered to patients.

Epinephrine is a critical medication used in life-threatening conditions that can affect people of all ages. Spectrum Epinephrine USP bulk API Powder is widely used for the manufacturing and compounding of epinephrine prescription products that can be used to treat a wide range of medical problems, including anaphylaxis attacks, hypersensitivity reactions, asthma, etc.

The drug is also used in conditions requiring immediate medical attention like bronchospasm, airway edema, nasal congestion, dilation during intraocular surgery, vasoconstrictors, heart failure, and other medical implications.

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All you need to know about Spectrum Epinephrine (L-Adrenaline) USP recall

Labels of the recalled 1 gram and 5 grams Spectrum Epinephrine Bulk API Powder drug (L-Adrenaline) USP drug (Image via FDA)

The recalled Spectrum Epinephrine (L-Adrenaline) USP drugs have been distributed to distributors, wholesalers, hospitals, and other medical institutions across the United States over the last few months. Though the drug was meant to be used by doctors and other medical professionals, it was also distributed in limited numbers at retail stores across the country.

The recall affects at least three lots of Spectrum Epinephrine (L-Adrenaline) USP that were packaged in amber glass bottles enclosed in a vacuum-sealed pouch of various package sizes. The recalled Epinephrine drug falls under the Spectrum catalog number EP130.

Customers can recognize the affected products by checking the label on the bottles for the following details:

Product	NDC	Package Size	Lot #	Exp Date
Epinephrine, USP (Product code EP130)	49452-2740-2	1 KG	1KG0865	31-Mar-2023
Epinephrine, USP (Product code EP130)	49452-2740-1	100 GM	2KL0353 2KF0151	30-Sep-2023 31-Mar-2023
Epinephrine, USP (Product code EP130)	49452-2740-4	1 GM	2KL0353 2KF0151	30-Sep-2023 31-Mar-2023
Epinephrine, USP (Product code EP130)	49452-2740-3	25 GM	2KL0353 2KF0151	30-Sep-2023 31-Mar-2023
Epinephrine, USP (Product code EP130)	49452-2740-5	5 GM	2KL0353 2KF0151	30-Sep-2023 31-Mar-2023

Distributors, wholesalers, and retailers have been urged to immediately stop the recalled drugs' distribution. All hospitals, medical institutions, and doctors should also discontinue the use of the recalled drugs.

Consumers who may have access to the recalled Epinephrine are strictly advised not to use it. All stocks of the recalled drug are to be returned to the place of purchase for a complete refund.

Labels of 25 grams and 100 grams lots under the Spectrum Epinephrine Bulk API Powder recall (L-Adrenaline) USP drug (Image via FDA)

Customers, medical professionals, retailers, and others who may have doubts or queries regarding the recall can reach out to Spectrum Laboratory Products, Inc. at 800-772-8786, Monday to Friday, from 8 am to 5 pm Pacific Time. The company can also be reached via email at [email protected].