FDA-Drug2023-02-01Class I

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.

Spectrum Laboratory Products, Inc.
Hazard

Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

Sold states
Nationwide in the USA, Puerto Rico and Canada
Affected count
7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G
Manufactured in
755, 769 And 777 Jersey Ave, N/A, New Brunswick, NJ, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0180-2023

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