Spectrum Laboratory Products recalls
FDA enforcement reports naming Spectrum Laboratory Products as the recalling firm.
- Recall reports
- 9
- Class I (serious)
- 2
- Most recent report
- Feb 1, 2023
- Feb 1, 2023Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum seale…Drug · Spectrum Laboratory Products, Inc.Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective productClass I
- Feb 1, 2023Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacu…Drug · Spectrum Laboratory Products, Inc.Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective productClass I
- Feb 12, 2020Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg CorpDrug · Spectrum Laboratory ProductsCGMP Deviations: Presence of NDMA impurity detected in product.Class II
- Jan 1, 2020Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triolDrug · Spectrum Laboratory ProductsSubpotent Drug: Supplier indicated assay results did not meet specifications.Class II
- Oct 23, 2019Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFGDrug · Spectrum Laboratory ProductsCGMP Deviations: Received notice from supplier that there is potential glass contamination.Class II
- Jun 14, 2017Levonorgestrel, UDrug · Spectrum Laboratory Products, Inc.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…Class II
- Jun 14, 2017Estradiol (17-B-EstradiolDrug · Spectrum Laboratory Products, Inc.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…Class II
- Aug 17, 2016Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORPDrug · Spectrum Laboratory Products, Inc.Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.Class II
- Nov 26, 2014Tetrahydrozoline Hydrochloride, USP, 1 KG BottleDrug · Spectrum Laboratory ProductsCGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.Class II