FDA Recall D-0180-2023

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, 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.

Lot / code: Lot # (a) (b) (c) (d) lot 2KL0353, EXP 30-Sep-2023; 2KF0151, EXP 31-Mar-2023

Quantity: 7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G

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-0180-2023
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

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