Spectrum Laboratory Products - Epinephrine

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.

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 was distributed directly from Spectrum facilities nationwide in the USA and to Canada.

Spectrum Laboratory Products, Inc. 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.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA