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Spectrum Laboratory Products, Inc.

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20161
20172
20232
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FDA Recall Terminated Historical recordClass I

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.

by Spectrum Laboratory Products, Inc.

Reason
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Published
February 1, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass I

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

by Spectrum Laboratory Products, Inc.

Reason
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Published
February 1, 2023
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code L1229.

by Spectrum Laboratory Products, Inc.

Reason
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Published
June 14, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmaceutical ingredient, packaged in 1g, 5g, 25g, 6 x 25g, and 100g containers, Rx only, Spectrum Chemical Mfg. Corp, Gardena, CA 90248, New Brunswick, NJ 08901, Product code E1435.

by Spectrum Laboratory Products, Inc.

Reason
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Published
June 14, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901

by Spectrum Laboratory Products, Inc.

Reason
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Published
August 17, 2016
Distribution
US: MA, TN, GA, MO and Canada

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Showing 1–5 of 5 results

This page lists recalls that name Spectrum Laboratory Products, Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.