FDA Drug recall D-0881-2017
Estradiol (17-B-Estradiol
- FDA Drug
- Class II
- terminated
- Published 2017-06-14
On 2017-06-14 the FDA classified a Class II recall of Estradiol (17-B-Estradiol by Spectrum Laboratory Products, citing CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from c….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0881-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-13 |
| Published | 2017-06-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Spectrum Laboratory Products |
| Distribution | US |
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.
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.
Identifiers
| code_info | Lot #: 2FH0257, Exp 09/30/2017; 2GA0254, Exp 03/24/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0881-2017%22
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