Safety Report: Spectrum Epinephrine bulk API - recalled due to product discoloration, USA

United States

Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical ingredient (API) used to manufacture or compound prescription products, to the user level. Customer complaints have found the product to be discolored. Product was distributed directly from Spectrum facilities nationwide in the USA and to Canada.

Risk Statement: Epinephrine is a critical medication used during life-threatening conditions which can affect any age and any person. 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. Treatment with a less-effective product, essentially underdosing epinephrine, could result in death. Spectrum Laboratory Products, Inc. has not received any reports of adverse events related to this recall.

Epinephrine (L-Adrenaline) USP bulk API Powder, is used in manufacturing and compounding of finished dose epinephrine prescription products which can be used to 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 Epinephrine (L-Adrenaline) USP bulk API Powder is packaged in amber glass bottles enclosed in a vacuum sealed pouch. NDC’s, Package sizes, lot numbers and expiration dates can be found in the table below. The affected Epinephrine, USP product can be identified by Spectrum catalog number EP130.

Product: Epinephrine, USP (Product code EP130)
NDC: 49452-2740-2
Package Size: 1 KG
Lot # 1KG0865
Exp Date: 31-Mar-2023

Product: Epinephrine, USP (Product code EP130)
NDC: 49452-2740-1
Package Size:100 GM
Lot # 2KL0353 / 2KF0151
Exp Date: 30-Sep-2023 / 31-Mar-2023

Product: Epinephrine, USP (Product code EP130)
NDC: 49452-2740-4
Package Size: 1 GM
Lot # 2KL0353 / 2KF0151
Exp Date: 30-Sep-2023 / 31-Mar-2023

Product: Epinephrine, USP (Product code EP130)
NDC: 49452-2740-3
Package Size: 25 GM
Lot # 2KL0353 / 2KF0151
Exp Date: 30-Sep-2023 / 31-Mar-2023

Product: Epinephrine, USP (Product code EP130)
NDC: 49452-2740-5
Package Size: 5 GM
Lot # 2KL0353 / 2KF0151
Exp Date: 30-Sep-2023 / 31-Mar-2023

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.

In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Spectrum Laboratory Products Inc.
Brand name: Spectrum
Product recalled: Epinephrine bulk API
Reason of the recall: Product discoloration
FDA Recall date: January 09, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/spectrum-laboratory-products-inc-issues-voluntary-worldwide-recall-epinephrine-l-adrenaline-usp-bulk