Estradiol -triene-3 recalled over manufacturing violations

Recall date

April 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 pharmac…

Recall number

D-0881-2017

FDA classification

Class II

Brand / firm

Spectrum Laboratory Products, Inc.

Sold / distributed

Nationwide in the USA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.