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Spectrum Laboratory Products Recalls
9 recalls on record · November 26, 2014 to February 1, 2023 · Drugs
Recalls by year
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23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 1, 2023DrugsFDA
Spectrum Laboratory Products, Inc. recalls Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1
Hazard: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
February 1, 2023DrugsFDA
Spectrum Laboratory Products, Inc. recalls Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by S
Hazard: Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
February 12, 2020DrugsFDA
Spectrum Laboratory Products recalls Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100
Hazard: CGMP Deviations: Presence of NDMA impurity detected in product.
January 1, 2020DrugsFDA
Spectrum Laboratory Products recalls Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G gla
Hazard: Subpotent Drug: Supplier indicated assay results did not meet specifications.
October 23, 2019DrugsFDA
Spectrum Laboratory Products recalls Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-0
Hazard: CGMP Deviations: Received notice from supplier that there is potential glass contamination.
June 14, 2017DrugsFDA
Spectrum Laboratory Products, Inc. recalls Levonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, Spectrum Chemical Mfg. Cor
Hazard: 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.
June 14, 2017DrugsFDA
Spectrum Laboratory Products, Inc. recalls Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active pharmace
Hazard: 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.
August 17, 2016DrugsFDA
Spectrum Laboratory Products, Inc. recalls Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New Brunswick, NJ 08901
Hazard: Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
November 26, 2014DrugsFDA
Spectrum Laboratory Products recalls Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.
Hazard: CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.