FDA recall D-0179-2023

Spectrum Laboratory Products, Inc. · Class I · drug

Product

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

Distribution

Nationwide in the USA, Puerto Rico and Canada

Key facts

Status
Terminated
Initiation date
2022-12-19
Report date
2023-02-01
Termination date
2025-08-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
New Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0179-2023