Home / Recalls / Spectrum Laboratory Products / D-0255-2015

D-0255-2015 Class II Terminated

Recalled by Spectrum Laboratory Products — Gardena, CA

Recall Details

Product Type
Drugs
Report Date
November 26, 2014
Initiation Date
July 18, 2014
Termination Date
November 24, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
16 Bottles

Product Description

Tetrahydrozoline Hydrochloride, USP, 1 KG Bottle. Spectrum Chemical MFG CORP., Gardena, CA 90248. Cat. YY1568.

Reason for Recall

CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.

Distribution Pattern

U.S.: California.

Code Information

Lot #: 1BJ0479; Expiry: 06/2017

Other recalls by Spectrum Laboratory Products

  • D-0180-2023 Class I — Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in (December 19, 2022)
  • 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-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-0881-2017 Class II — Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant (April 13, 2017)
  • D-1456-2016 Class II — Zinc Acetate, Crystal, USP, packaged in 500 gram bottles, Spectrum Chemical MFG, (August 1, 2016)