FDA Drug recall D-0628-2020
Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol
- FDA Drug
- Class II
- terminated
- Published 2020-01-01
On 2020-01-01 the FDA classified a Class II recall of Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol by Spectrum Laboratory Products, citing subpotent Drug: Supplier indicated assay results did not meet specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0628-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-11 |
| Published | 2020-01-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Spectrum Laboratory Products |
| Distribution | US |
Product
Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248.
Reason
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Identifiers
| code_info | Lot #s: 1HG0308, 1HH0630, 1HI0854, 4HL0005,4HL0036, 4IH0032, Exp. 04/16/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0628-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.