Last Updated on December 31, 2023 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.
| Product | NDC | Package Size | Lot # | Exp Date |
|---|---|---|---|---|
| Epinephrine, USP (Product code EP130) | ||||
| 49452-2740-2 | 1 KG | 1KG0865 | 31-Mar-2023 | |
| 49452-2740-1 | 100 GM | 2KL0353 2KF0151 | 30-Sep-2023 31-Mar-2023 | |
| 49452-2740-4 | 1 GM | |||
| 49452-2740-3 | 25 GM | |||
| 49452-2740-5 | 5 GM |
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (USFDA).
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