FDAFDA · Food and drugs·Recall number D-0881-2017
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.
Published June 14, 2017 · Recall initiated: April 13, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Spectrum Laboratory Products, Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 2FH0257, Exp 09/30/2017; 2GA0254, Exp 03/24/2018
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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