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

FDA recall notice · announced February 1, 2023 · Spectrum Laboratory Products

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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

Notes

Distribution: Nationwide in the USA, Puerto Rico and Canada
Lot/code information: Lot # 1KG0865 EXP 31-Mar-2023
Quantity: 1 bottle
Status: Terminated
Products in this recall event:
- 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. Garde (D-0180-2023)
- 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 (D-0179-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.