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.
Other recalls by Spectrum Laboratory Products
- Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G
FDA Drug · Class I · 2023-02-01 · Spectrum Laboratory Products - Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg
FDA Drug · Class I · 2023-02-01 · Spectrum Laboratory Products - Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams…
FDA Drug · Class II · 2020-02-12 · Spectrum Laboratory Products - Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06
FDA Drug · Class II · 2019-10-23 · Spectrum Laboratory Products - Estradiol (17-B-Estradiol
FDA Drug · Class II · 2017-06-14 · Spectrum Laboratory Products
All Spectrum Laboratory Products recalls
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.