Drug product
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.
D-0881-2017
Product summary
- Event
- Event 77398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48 containers
- Official record key
drug-enforcement:D-0881-2017
Official wording
Reason: 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.
Code information: Lot #: 2FH0257, Exp 09/30/2017; 2GA0254, Exp 03/24/2018
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations