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| The United States: Spectrum Laboratory Products, Inc. issues voluntary worldwide recall of Epinephrine (L-Adrenaline) USP bulk active pharmaceutical ingredient (API) due to discoloration of product (English only) |
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The US Food and Drug Administration (FDA) announces that 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.
The affected lot numbers are:
- 1KG0865 (package size: 1kg)
- 2KL0353, 2KF0151 (package size: 1g, 5g, 25g, 100g)
The Epinephrine (L-Adrenaline) USP bulk API Powder is packaged in amber glass bottles enclosed in a vacuum sealed pouch.
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, Inc. has not received any reports of adverse events related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/spectrum-laboratory-products-inc-issues-voluntary-worldwide-recall-epinephrine-l-adrenaline-usp-bulk
In Hong Kong, the above product is not a registered pharmaceutical substance.
Ends/Wednesday, Jan 11, 2023
Issued at HKT 15:00
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