Spectrum Laboratory Products, Inc.

FDA Regulatory Profile

Summary

Total Recalls
9 (2 Class I)
510(k) Clearances
0
Inspections
17
Compliance Actions
2

Recent Recalls

NumberClassProductDate
D-0180-2023Class IEpinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouDecember 19, 2022
D-0179-2023Class IEpinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx oDecember 19, 2022
D-0825-2020Class IIRanitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams,January 14, 2020
D-0628-2020Class IIEstriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, paDecember 11, 2019
D-0141-2020Class IIFentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90September 12, 2019
D-0882-2017Class IILevonorgestrel, U.S.P. active pharmaceutical ingredient, packaged in 1 kg container, Rx only, SpectrApril 13, 2017
D-0881-2017Class IIEstradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, UApril 13, 2017
D-1456-2016Class IIZinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, CORP., New BrunswicAugust 1, 2016
D-0255-2015Class IITetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. CJuly 18, 2014