Spectrum Laboratory Products, Inc. recalls Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by…
- Recall date
- December 19, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0179-2023
- FDA classification
- Class I
- Brand / firm
- Spectrum Laboratory Products, Inc.
- Sold / distributed
- Nationwide in the USA, Puerto Rico and Canada
Why it was recalled
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. Product Code EP130
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