D-0881-2017 Class II Terminated
FDA drug recall D-0881-2017 was initiated by Spectrum Laboratory Products, Inc. on Apr 13, 2017 and is designated Class II. 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… The recall status is terminated (terminated Feb 21, 2019). Affected quantity: 48 containers.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 14, 2017
- Initiation Date
- Apr 13, 2017
- Termination Date
- Feb 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48 containers
Product Description
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.
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 Pattern
Nationwide in the USA
Code Information
Lot #: 2FH0257, Exp 09/30/2017; 2GA0254, Exp 03/24/2018
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0881-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026