Home / Recalls / Spectrum Laboratory Products, Inc. / D-0180-2023

D-0180-2023 Class I Terminated

Recalled by Spectrum Laboratory Products, Inc. — New Brunswick, NJ

Recall Details

Product Type
Drugs
Report Date
February 1, 2023
Initiation Date
December 19, 2022
Termination Date
August 19, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G

Product Description

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.

Reason for Recall

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

Distribution Pattern

Nationwide in the USA, Puerto Rico and Canada

Code Information

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

Other recalls by Spectrum Laboratory Products, Inc.

  • D-0179-2023 Class I — Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuu (December 19, 2022)
  • D-0825-2020 Class II — Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) (January 14, 2020)
  • D-0628-2020 Class II — Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, (December 11, 2019)
  • D-0141-2020 Class II — Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. C (September 12, 2019)
  • D-0882-2017 Class II — Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg contai (April 13, 2017)
  • D-0881-2017 Class II — Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant (April 13, 2017)
  • D-1456-2016 Class II — Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, (August 1, 2016)
  • D-0255-2015 Class II — Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., (July 18, 2014)