Epinephrine (L-Adrenaline) Recall - Due to Discoloration of Product
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.
Spectrum Laboratory Products is recalling three lots, 1KG0865, 2KL0353 and 2KF0151 of Epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical ingredient (API) used to manufacture or compound prescription products. Customer complaints have found the product to be discolored.
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 has not received any reports of adverse events related to this recall.
- Patients, 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.
- Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
- Patients with questions regarding this recall can contact the company.
Patients and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report online.
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.
Click here to read the FDA Spectrum Laboratory Products Voluntary Recall