Drug & medication recalls High risk

Spectrum Laboratory Products, Inc. recalls Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)…

Recall date
December 19, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0180-2023
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, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901.

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