Reported Jun 14, 2017 · Terminated
Estradiol (17-B-Estradiol; Estra-1,3,5(10)-triene-3, 17B-diol; Oestradiol) Plant Base, Micronized, U.S.P active…
Spectrum Laboratory Products, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spectrum Laboratory Products, Inc. · 755 and 769 Jersey Ave · New Brunswick, NJ · 08901-3605
Is this the product you have?
Estradiol (17-B-EstradiolEstra-135(10)-triene-317B-diolOestradiol) Plant BaseMicronizedU.S.P active pharmaceutical ingredientpackaged in 1g5g25g6 x 25gand 100g containersRx onlySpectrum Chemical Mfg. CorpGardenaCA 90248New BrunswickNJ 08901Product code E1435
- Lot codes and dates
Lot #: 2FH0257Exp 09/30/20172GA0254Exp 03/24/2018
- Amount recalled
- 48 containers
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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