Home / Recalls / Spectrum Laboratory Products, Inc. / D-0881-2017

D-0881-2017 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
June 14, 2017
Initiation Date
April 13, 2017
Termination Date
February 21, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
48 containers

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationwide in the USA

Code Information

Lot #: 2FH0257, Exp 09/30/2017; 2GA0254, Exp 03/24/2018

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-0180-2023 Class I — Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in (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-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)