Class II
Terminated
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.
- Recall Initiated
- April 13, 2017
- Posted
- June 14, 2017
- Recall Number
- D-0881-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 48 containers
- Firm Location
- New Brunswick, NJ, United States
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
Nationwide in the USA
Lot / Code Info
Lot #: 2FH0257, Exp 09/30/2017; 2GA0254, Exp 03/24/2018
More recalls by Spectrum Laboratory Products, Inc.
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