Spectrum Laboratory Products Issues Recall of Epinephrine USP Bulk API Due to Discoloration

Spectrum Laboratory Products announced on Jan. 9, 2023 that the company is voluntarily recalling three lots of epinephrine (L-Adrenaline) USP, a bulk API used to manufacture or compound prescription products to the user level.

The L-Adrenaline USP bulk API powder is used in manufacturing and compounding of finished-dose epinephrine prescription products that 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.

Epinephrine is a critical medication used during life-threatening conditions that can affect any age and any person. 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, such as low blood pressure, heart failure, anaphylaxis, irregular heartbeat, and heart attack. Further, treatment with a less-effective product or underdosing of epinephrine could result in death.

The main customer complaints have found that the product is discolored. The doses that are included in the impacted Epinephrine USP product can be identified by Spectrum catalog number EP130.

There have not been any reports of adverse events related to this recall, according to Spectrum Laboratory Products.

Source: US FDA