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www.fdanews.com/articles/210792-spectrum-issues-recall-of-epinephrine-api-due-to-discoloration-reports

Spectrum Issues Recall of Epinephrine API Due to Discoloration Reports

January 12, 2023

Spectrum Laboratory Products has recalled three lots of epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical ingredient (API) used to treat conditions such as anaphylaxis and other severe hypersensitivity reactions.

The bulk API is used in manufactured or compounded prescription products. The recall follows customer complaints of the epinephrine products being discolored.

The risk of using less effective epinephrine products could result in death, the company said.

The affected products were distributed directly from Spectrum’s facilities in the U.S. and Canada and can be identified by the catalog number EP130. The company has not received any reports of adverse events related to this recall.

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