PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: February 1, 2023 Initiated: December 19, 2022 #D-0179-2023

Product Description

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

Reason for Recall

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

Details

Units Affected
1 bottle
Distribution
Nationwide in the USA, Puerto Rico and Canada
Location
New Brunswick, NJ

Frequently Asked Questions

What product 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. Recalled by Spectrum Laboratory Products, Inc.. Units affected: 1 bottle.
Why was this product recalled?
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Which agency issued this recall?
This recall was issued by the FDA Drug on February 1, 2023. Severity: Critical. Recall number: D-0179-2023.