- U.S. Food and Drug Administration (FDA) (http://dev-voice.ons.org/topic/us-food-and-drug-administration-fda)
- Safety (http://dev-voice.ons.org/topic/safety)
- Healthcare Safety Standards (http://dev-voice.ons.org/topic/healthcare-safety-standards)
- Clinical Practice (http://dev-voice.ons.org/topic/clinical-practice)
Spectrum Laboratory Products, Inc., Issues Voluntary Recall of Epinephrine USP, Bulk API, Because of Product Discoloration
On January 9, 2022, the U.S. Food and Drug Administration reported (https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/spectrum-laboratory-products-inc-issues-voluntary-worldwide-recall-epinephrine-l-adrenaline-usp-bulk?utm_medium=email&utm_source=govdelivery) that Spectrum Laboratory Products, Inc., issued a voluntarily recall of three lots of epinephrine (l-adrenaline), USP, used to manufacture or compound prescription products, at the user level because of customer reports that the product is discolored.
Epinephrine USP is a critical medication used during life-threatening conditions in people of any age. The use of a finished dose product manufactured or compounded with the recalled product could result in a less-effective product and incomplete treatment of life-threatening conditions, such as low blood pressure, heart failure, anaphylaxis, irregular heartbeat, and heart attack, and could result in death. Spectrum Laboratory Products, Inc., said it has not received any reports of adverse events related to the recall.
The powder is packaged in amber glass bottles enclosed in a vacuum-sealed pouch. The recalled product was distributed from Spectrum Laboratory Products, Inc., to facilities nationwide in the United States and Canada. Epinephrine USP bulk API powder is packaged in amber glass bottles enclosed in a vacuum-sealed pouch. The recalled product was distributed from Spectrum Laboratory Products, Inc., to facilities nationwide in the United States and Canada.
The following product is included in the recall:
| Product | Product Code | NDC | Package Size | Lot Number | Expiration Date |
| Epinephrine, USP | EP130 | 49452-2740-2 | 1 kg | 1KG0865 | March 31, 2023 |
| 49452-2740-1 | 100 gm | 2KL0353; 2KF0151 |
September 30, 2023; March 31, 2023 |
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| 49452-2740-4 | 1 gm | 2KL0353; 2KF0151 |
September 30, 2023; March 31, 2023 |
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| 49452-2740-3 | 25 gm | 2KL0353; 2KF0151 |
September 30, 2023; March 31, 2023 |
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| 49452-2740-5 | 5 gm | 2KL0353; 2KF0151 |
September 30, 2023; March 31, 2023 |
Consumers with questions regarding the recall should contact Spectrum Laboratory Products, Inc., at 800-772-8786 or compliance@spectrumchemical.com (mailto:compliance@spectrumchemical.com) from Monday–Friday, 8 am–5 pm PST. Consumers should contact their physician or healthcare provider if they experience any problems that may be related to taking or using the recalled product.Spectrum Laboratory Products, Inc., is notifying distributors and customers by mail, email, and phone, and is arranging for return of the recalled product. Consumers, distributors, or retail pharmacies that have the recalled product should immediately stop use and return it to place of purchase.
Healthcare professionals and consumers should report any adverse reactions or quality problems (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.