FDA Announces Recall of Epinephrine

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The U.S. Food and Drug Administration (FDA) announced the recall of three epinephrine lots, used to treat severe allergic reactions, after consumer complaints.

According to an announcement, manufacturer Spectrum Laboratory Products said it voluntarily recalled the lots after the product was found to be discolored.

Epinephrine is placed in autoinjectors, the most common of which are sold under the EpiPen brand name. They’re often used for people who have severe food allergies or asthma.

Spectrum’s epinephrine is packaged in amber glass bottles enclosed in a vacuum-sealed pouch, and the recall is for tracking catalog number EP130. It covers lot numbers 1KG0865 and 2KF0151 with the expiration date of Mar. 31, 2023, in sizes 100 gm, 25 gm, 5 gm, and 1 gm, as well as and lot 2KL0353 with the expiration date of Sept. 30, 2023. The drug’s labels can be accessed via the FDA’s website.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/spectrum-laboratory-products-inc-issues-voluntary-worldwide-recall-epinephrine-l-adrenaline-usp-bulk

Consumers, distributors, or pharmacies that have epinephrine USP with the catalog number EP130 should immediately stop using the product and return it to the place of purchase, said the announcement. It was distributed from Spectrum facilities in the United States and Canada.

“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,” the recall bulletin also said. “Treatment with a less-effective product, essentially underdosing epinephrine, could result in death.”