FDA Recall D-0179-2023
Spectrum Laboratory Products, Inc. · New Brunswick, NJ
Class I — life-threatening Terminated 974 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-0179-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA, Puerto Rico and Canada
- Recall initiated
- 2022-12-19
- Classified by FDA Center
- 2023-01-25
- FDA published
- 2023-02-01
- Terminated
- 2025-08-19
- Recalling firm
- Spectrum Laboratory Products, Inc.
- Firm location
- New Brunswick, NJ