Drug recall: Epinephrine API recalled due to this reason

Treatment with a less-effective product, essentially underdosing epinephrine, could result in death.

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Drug recall
Drug recall

Last Updated on October 15, 2024 by The Health Master

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.

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,
  • 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.

Use of Epinephrine (L-Adrenaline) USP bulk API Powder:

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,
  • 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.

ProductNDCPackage SizeLot #Exp Date
Epinephrine, USP (Product code EP130)
49452-2740-21 KG1KG086531-Mar-2023
49452-2740-1100 GM2KL0353
2KF0151
30-Sep-2023
31-Mar-2023
49452-2740-41 GM
49452-2740-325 GM
49452-2740-55 GM

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

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